Job Title:      Associate Director to Director, Analytical, Physicochemical & Aerosol Analysis OINDPs

Job Level:   

Location:      Weston, FL (near Miami, FL and Fort Lauderdale, FL)

Function:      R&D, Product Development

Reports to:   Chief Scientific Officer (CSO)

Job Specific Information

Summary

Manages a team of laboratory scientists conducting standard and advanced laboratory activities. Independently designs, conducts, leads, supervises and troubleshoots, physico-chemical characterization studies with a focus on liquid chromatography (LC), spectroscopy, and aerosol performance techniques for orally inhaled and nasal drug products (OINDP). Supports evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for OINDPs following cGMP, Transpire Bio EH&S and other relevant guidelines. Leads the development and evaluation of new physico-chemical characterization and aerosol analytical technologies where required. Initiates investigations and data reviews. Manages resources and assures progress of project activities on a daily basis. Coaches, mentors and trains team members. Communicates data summaries, study observations and recommendations to Executive Management.

Essential Duties and Responsibilities

• Manage a group of laboratory scientists conducting standard and advanced laboratory activities.
• Independently design, conduct, lead and supervise liquid chromatography (LC), spectroscopy, and aerosol performance characterization studies for orally inhaled and nasal drug products (OINDP).
• Provide leadership in CMC activities and represent CMC on global project teams.
• Act as subject matter expert (SME) on physico-chemical and aerosol analytical characterization methodologies for OINDPs.
• Lead characterization studies for evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for OINDPs following cGMP, EH&S and other relevant guidelines of Transpire Bio, FDA and other governing bodies.
• Supervise and lead the execution of analytical activities required for regulatory submission including method development, verification, transfer and validation protocols of analytical methods. Participate in laboratory activities as required.
• Write protocols, methods, reports, standard operation procedures, and submission documents, when required.
• Analyze data, identify trends and perform statistical analysis. Present data, recommendations and conclusions to senior management on a regular basis.
• Lead project activities, support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers. Work and communicate effectively with other functional groups.
• Troubleshoot technical issues, analyze data, identify solutions, and implement recommendations.
• Plan laboratory activities and resources on a weekly basis and ensure that project timelines are met consistently.
• Develop and communicate project plans, goals and strategies to the group.
• Propose and implement processes and new technologies that lead to increased efficiencies and quality of laboratory activities. Drive the continuous improvement process.
• Develop and implement appropriate training programs for analytical activities across all groups.
• Mentor and assist junior scientists.
• Ensure that members of the group are trained on relevant methods, policies and procedures. Verify that training records of group members are updated per organization policies. Conduct quarterly performance reviews of group members and provide them with regular feedback. Support the personal development of group members.
• Influence decisions within team.
• Establish and maintain effective relationships with team members.
• Ensure lab work is conducted in accordance with SOPs; follow Transpire Bio safety rules and procedures.
• Comply with all Transpire Bio Corporate guidelines and policies.

Qualification Requirements

• Ph.D. in Analytical Chemistry / Chemistry / Pharmaceutics/ Pharmaceutical Technology or related fields with a minimum of 12 – 15 years of relevant experience; Minimum 17 – 20 years’ experience in pharmaceutical technology or related fields without a Ph.D.
• In depth knowledge of pharmaceutical and inhalation technology.
• Relevant experience in characterization of orally inhaled and nasal drug products OINDPs.
• Extensive knowledge of analytical chemistry methodologies (UPLC/HPLC, GC, UV, FTIR etc.) and aerosol characterization methodologies (Cascade Impaction, Laser Diffraction techniques etc.).
• Experience in supervising 6-10 laboratory scientists.
• Experience in planning, organization and project management.

• Knowledge and detailed understanding of the FDA cGMP requirements as they apply to the Pharmaceutical industry. Good understanding of USP methodologies and ICH
• Strong English language skills including writing ability and oral communication.
• Advanced ability to utilize MS Office communication tools for scientific and management communications.
• Ability to utilize statistical data packages for data processing and communication is a good to have.

Job Title:      Associate Scientist I

Site:                Miami, Florida

Function:      CMC

Department: Transpire Bio

Essential Duties and Responsibilities

• Conduct basic laboratory activities including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
• Set up and operate lab equipment. Prepare reagents, solvents and solutions for analytical and formulation activities. Prepare and maintain accurate records in lab notebooks of all tests performed. Process analytical data on lab equipment such as HPLC/UPLC, enter data in spreadsheets and conduct routine. calculations. Support the manufacture of inhalation drug products. Prepare samples for blend uniformity as required.
• Participate in project team activities and support project timelines and proactively contribute to meeting team objectives.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs & STPs; follow Corporate health & safety rules and procedures.
• Comply with Corporate guidelines and policies.

Qualification Requirements

• BSc in Chemistry, Pharmacy or related fields with 0-2 years of experience.
• Computer literacy and familiarity with analytical and/or process equipment used in laboratories such as HPLC, IR/FTIR, UV-Vis AA, powder blender etc.
• Effective English written and oral communication skills.

Job Title:      Associate Scientist II

Site:                Miami, Florida

Function:      CMC

Department: Transpire Bio

Essential Duties and Responsibilities

• Conduct laboratory activities with limited supervision including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
• Independently set up and operate lab equipment, prepare reagents, solvents and solutions for analytical and formulation activities. Prepare and maintain accurate records in lab notebooks of all testing performed. Process analytical data on lab equipment such as HPLC/UPLC, enter data in spreadsheets and conduct routine calculations. Support the manufacture of inhalation drug product. Prepare samples for blend uniformity.
• Perform equipment qualification and calibrations as directed.
• Execute approved method transfer protocols.
• Assist in the training of other scientists.
• Perform other tasks as assigned.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicates effectively with team members.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs & STPs; follow Corporate safety rules and procedures
• Comply with all Corporate guidelines and policies

Qualification Requirements

• BSc in Chemistry, Pharmacy or related fields with at least 3 years of experience in Pharmaceutical R&D
• MSc in Chemistry, Pharmacy or related fields with 0-2 years of experience in Pharmaceutical R&D
• Proven ability and/or experience with compendial test methods or pharmaceutical manufacturing equipment.
• Understanding of pharmaceutical equipment and computerized systems for operation and troubleshooting. Specific experience with analytical and/or process equipment used in laboratories such as HPLC, IR/FTIR, UV-Vis AA, powder blender etc.
• Knowledge and understanding of the FDA cGMP requirements as it applies to the Pharmaceutical industry.
• Effective English written and oral communication skills. Ability to write short technical documents such as memos, laboratory investigations, protocols and reports.

Job Title:         Device Mechanical Engineer, Pharmaceutical R&D, Drug-Device Combination Products

Job Level:       

Location:        Weston, FL (near Miami and Fort Lauderdale, Florida (FL))

Function:        R&D, Product Development

Reports to:     Director, Device Engineering

Job Specific Information

Summary

Responsible for device engineering activities in the context of pharmaceutical research and development (R&D).  The device mechanical engineer will be responsible for early to late-stage device development activities and commercialization of drug-device combination products. Device engineer will be responsible for design, prototyping, technical analysis, and testing of orally inhaled and nasal drug products (OINDPs). Provide device engineering leadership in the direction, initiation, planning, coordination, implementation, execution, control, and completion of specific device project(s) ensuring consistency with organizational strategy, commitments, and goals. The device engineer will need to ensure that the device designs meet user needs, regulatory and quality requirements, and consider manufacturability. This is a hands-on position which requires daily tactical responsibilities leading up to strategic decisions.

Essential Duties and Responsibilities

• In support of the Product Development Teams, provide technical leadership in the device development area.
• Execute design and development of orally inhaled and nasal drug products (OINDPs) following design controls.
• Lead and execute analysis for device and product characterization, design feasibility, and design verification.
• Lead and execute technical analyses including statistical analysis and tolerance analysis.
• Lead root cause investigations.
• Support scale-up and commercialization efforts.
• Document studies and author documents per US FDA, EMA, MHRA and other global health authority requirements.
• Interface and lead activities with third party contract research, development, and manufacturing organizations.
• Contribute towards and maintain device design history files (DHF).
• Document standard operating procedures (SOPs) for design controls in the context of

pharmaceutical drug-device combination products.

• Provide project updates/reporting through program governance.
• Provide leadership and support for inter-site best practices (technology transfer, process validation, etc.) and phase appropriate guidelines and policies.
• Execute project strategy, priorities, and milestones ensuring visibility and accountability.
• Proactively lead with integrity and engage cross functional project teams and stakeholders.
• Support organizational / departmental initiatives.
• Prepare and conduct presentations to all levels of the organization which may include project technical and budgetary information.

Qualification Requirements

• A M.S, in Mechanical Engineering, Electrical Engineering, Material Sciences or related discipline with 3 to 6 years, B.S. with 8 to 12 years device development experience in pharmaceutical or related field.
• Experience with device development in the context of pharmaceutical R&D and product development is a must to have.
• Must possess expert knowledge of mechanical design with preference for SolidWorks.
• Must possess expert knowledge of tools to conduct statistical and tolerance analysis.
• Must possess knowledge of manufacturing processes including injection molding and metal machining processes.
• Must possess knowledge of regulations and standards including US 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, EU MDR etc.
• Experience with device assembly processes including manual, semi-automated and/or commercial scale automated processes is a plus.
• Experience in development of orally inhaled and nasal drug products (OINDPs) is a plus.
• Experience in mold tool design, optimization and qualification is a plus to have.
• Experience with Notified Bodies and CE marking is a plus.
• Strong English language skills including writing ability and oral communication.
• Demonstrates good judgment as well as cultural, social, and environmental awareness.

Job Title:         Device Mechanical Engineer, Manufacturing and Automation, Pharmaceutical R&D, Drug-Device Combination Products

Job Level:       

Location:        Weston, FL (near Miami and Fort Lauderdale, Florida (FL))

Function:        R&D, Product Development

Reports to:     Director, Device Engineering

Job Specific Information

Summary

Responsible for device engineering activities in the context of pharmaceutical research and development (R&D).  The device engineer will be responsible for commercial manufacturing processes including semi-automated to automated and large-scale manufacturing and assembly operations. The device engineer will utilize industry standard and novel equipment, processes, and methodologies to transform raw materials, components, and parts into finished goods to the required standards of safety, quality, cost and delivery across supply chain channels. The device engineer will be responsible for developing, maintaining, and optimizing the supply chain with a keen eye for cost of goods (COGS) as applicable to raw material, manufacturing processes and overall supply chain. This position will be focused on orally inhaled and nasal drug products (OINDPs). The device engineer will interface with early device design teams and be responsible for independently providing direction, initiation, planning, coordination, implementation, execution, control, and completion of specific device project(s) ensuring consistency with organizational strategy, commitments, and goals. This is a hands-on position which requires daily tactical responsibilities leading up to strategic decisionsEssential Duties and Responsibilities

• In support of the Product Development Teams, provide technical leadership in the device development area.
• Lead and execute manufacturing activities of devices with a focus on orally inhaled and nasal drug products (OINDPs).
• Responsible for developing and implementing best practices for manufacturing commercial products.
• Develop, propose, and implement vision, strategy, policies, processes, and procedures to aid and improve business performance.
• Lead scale-up and commercialization efforts.
• Lead root cause investigations.
• Lead life-cycle management efforts.
• Lead and execute technical analyses including statistical analysis and tolerance analysis.
• Document studies and author documents per US FDA, EMA, MHRA and other global health authority requirements.
• Interface and lead activities with third party contract research, development, and manufacturing organizations.
• Ensure that manufacturing strategies and processes are in place to meet business objectives and operational needs in terms of price, quality, and delivery targets and that enable the organization to function and compete effectively in the market.
• Proactively evaluate the challenges faced by the business and take actions to mitigate risks and develop opportunities.
• Contribute towards and maintain device design history files (DHF).
• Document standard operating procedures (SOPs) for design controls and manufacturing in the context of pharmaceutical drug-device combination products.
• Contribute towards overall business strategy and annual budget process.
• Provide project updates/reporting through program governance.
• Provide leadership and support for inter-site best practices (technology transfer, process validation, etc.) and phase appropriate guidelines and policies.
• Execute project strategy, priorities, and milestones ensuring visibility and accountability.
• Proactively lead with integrity and engage cross functional project teams and stakeholders.
• Support organizational / departmental initiatives.
• Prepare and conduct presentations to all levels of the organization which may include project technical and budgetary information.

Qualification Requirements

• A M.S, in Mechanical Engineering, Electrical Engineering, Material Sciences or related discipline with 6 to 9 years, B.S. with 12 to 16 years device development experience in pharmaceutical or related field.
• Experience with device development and manufacturing in the context of pharmaceutical R&D and product development is a must to have.
• Must possess expert knowledge and experience with commercial scale device manufacturing and assembly processes including manual, semi-automated and/or commercial scale automated processes.
• Must possess expert knowledge of manufacturing processes including injection molding and metal machining processes.
• Must possess expert knowledge of mold tool design, optimization, qualification and life-cycle management.
• Must possess expert knowledge of mechanical design with preference for SolidWorks.
• Must possess expert knowledge of tools to conduct statistical and tolerance analysis.
• Must possess knowledge of regulations and standards including US 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, EU MDR etc.
• Experience in development of orally inhaled and nasal drug products (OINDPs) is a plus.
• Experience with Notified Bodies and CE marking is a plus.
• Strong English language skills including writing ability and oral communication.
• Demonstrates good judgment as well as cultural, social, and environmental awareness.

Job Title:         Senior Scientist 1 to Principal Scientist, Formulations, Orally Inhaled and Nasal Products (OINDPs)

Job Level:       

Location:        Weston, FL (near Miami and Fort Lauderdale, Florida (FL))

Function:        R&D, Product Development

Reports to:     Chief Scientific Officer (CSO)

Job Specific Information

Summary

Independently conducts, leads and supervises standard and advanced laboratory activities including evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for Orally Inhaled and Nasal Drug Products (OINDPs) following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines. Leads the development and evaluation of new formulation technologies where required. Initiates investigations, data reviews and coaches and trains junior scientific staff.

Essential Duties and Responsibilities

• Independently conduct, lead and supervise standard and advanced laboratory activities for the development of OINDP formulations following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines.
• Independently design and lead pre-formulation, formulation and process development studies to recommend selection of APIs, excipients, packaging material and manufacturing process.
• Independently design and develop manufacturing processes and conduct manufacturing activities for OINDP products.
• Possess good understanding of other inhalation technologies.
• Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design.
• Provide expert support for manufacturing related technical issues.
• Write protocols, reports, methods and standard operation procedures.
• Write regulatory submission modules and any other documents to support submission and product approval.
• Develop statistical design of experiments with minimal supervision.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with Transpire Bio and Transpire Bio partner companies’ team members.
• Work and communicate effectively with other functional groups and across global respiratory R&D sites.
• Independently lead major project tasks.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs; follow Transpire Bio safety rules and procedures.
• Comply with all Transpire Bio Corporate guidelines and policies.

Qualification Requirements

• D., in Pharmaceutical Sciences or related discipline with 6 to 12 years, MS with 12+years research experience in pharmaceutical or related field.
• Must possess expert knowledge of development orally inhaled and nasal products (OINDPs).
• Knowledge of manufacturing processes of OINDP products is a plus.
• Knowledge and in-depth understanding of global regulatory requirements as applied to OINDPs.
• Excellent understanding of USP methodologies and ICH Deep knowledge of the FDA cGMP requirements as they apply to the pharmaceutical industry.
• Strong English language skills including writing ability and oral communication. Experience with writing of chemistry, manufacturing and control (CMC) sections of US and EU regulatory documents (NDA, ANDA, IND, IMPD).

Job Title:      Principal Scientist

Site:                Miami, Florida

Function:      CMC

Department: Transpire Bio

 Essential Duties and Responsibilities

• Supervise standard and advanced laboratory activities including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
• Design, develop and supervise the execution of approved method transfer protocols, development and validation of all analytical methods including excipients in drug products.
• Write regulatory submission modules and any other documents to support submission and product approval.
• Independently develop statistical design of experiments.
• Independently design and develop manufacturing processes and conduct manufacturing activities for inhalation drug products.
• Perform structure elucidation on unknown impurities. Provide possible formation pathway for degradation impurities and recommend preventive solutions.
• Evaluate and introduce new technologies to improve productivity and efficiency; be capable of generating new practical ideas and apply broad knowledge of related disciplines; drive continuous process improvement.
• Provide expert support for analytical and/or manufacturing related technical issues, analyzing data, identifying solutions, and implementing recommendations
• Develop and implement appropriate training programs for analytical or manufacturing activities across all respiratory development sites.
• Mentor and assist junior scientists
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers.
• Work and communicate effectively with other functional groups and across global respiratory R&D sites.
• Lead internal/external projects on specific CMC topics within a team environment.
• Contribute to innovative ideas and generation of innovative opportunities.
• Influence decisions on CMC
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs & STPs; follow Corporate Health & Safety rules and procedures.
• Comply with all Corporate guidelines and policies. 

Qualification Requirements

• PhD in Chemistry or Pharmacy or related fields with at least 12 years; MSc with at least 14 years or BSc with at least 17 years of experience in pharmaceutical or related fields.
• Extensive knowledge of analytical techniques including HPLC, GC, UV, FTIR and/or extensive knowledge of development and manufacturing activities for inhalation products.
• Knowledge and detailed understanding of global regulatory requirements as applied to Respiratory or Nasal delivery. Good understanding of USP methodologies and ICH Extensive knowledge of the FDA cGMP requirements as they apply to the Pharmaceutical industry.
• Strong English language skills including writing ability and oral communication.

Job Title:      Scientist I

Site:                Miami, Florida

Function:      CMC

Department: Transpire Bio

Essential Duties and Responsibilities

• Conduct standard and advanced laboratory activities with minimal supervision including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
• Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting; research and recommend corrective actions for out-of-specification and out-of-trend results.
• Execute approved method transfer protocols, develop and validate cleaning validation methods.
• Prepare and maintain accurate records in lab notebooks of all testing performed. Analyze data, identify trends and perform basic statistical calculations.
• Write protocols, reports, methods, standard operation procedures, and submission documents with supervision.
• Conduct manufacturing activities for drug products with limited supervision.
• Support the evaluation and introduction of new technologies.
• Independently train other scientists.
• Participate in project activities and support project timelines and proactively contribute to meeting team objectives. Communicate effectively with team members and internal or external customers. Work effectively with other functional groups. Lead small project tasks effectively, with some supervision.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs & STPs; follow Corporate health & safety rules and procedures.
• Comply with all Corporate guidelines and policies.

Qualification Requirements

• PhD in Chemistry or Pharmacy or related fields with 0-2 years; MSc with 3-5 years or BSc with a minimum of 5 years of experience in pharmaceutical or related fields.
• Must possess broad analytical chemistry knowledge in HPLC, GC, UV, FTIR and other related analytical technologies and/or basic knowledge of development and manufacturing inhalation drug products.
• Knowledge and understanding of the FDA cGMP requirements as they apply to the Pharmaceutical industry. Good understanding of USP methodologies and ICH

Strong English language skills including writing ability and oral communication.

Job Title:      Scientist II

Site:                Weston, Florida

Function:      CMC

Department: Transpire Bio

Essential Duties and Responsibilities

• Conduct standard and advanced laboratory activities with minimal supervision including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
• Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting; research and recommend corrective actions for out-of-specification and out-of-trend results.
• Execute approved method transfer protocols, develop and validate analytical methods.
• Prepare and maintain accurate records in lab notebooks of all testing performed.
• Analyze data, identify trends and perform basic statistical calculations.
• Write protocols, reports, methods, standard operation procedures, and submission documents with minimal supervision. Design experimental studies with some supervision.
• Conduct manufacturing activities for inhalation drug products with minimal supervision.
• Support the evaluation and introduction of new technologies; be capable of generating new practical ideas; possess good understanding of experimental design.
• Independently train other scientists.
• Participate in project activities and support project timelines and proactively contribute to meeting team objectives. Communicate effectively with team members and internal or external customers. Work and communicate effectively with other functional groups. Lead small project tasks effectively, with minimal supervision.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs & STPs; follow Corporate Health & Safety rules and procedures.
• Comply with all Corporate guidelines and policies.

Qualification Requirements

• PhD in Chemistry or Pharmacy or related fields with at least 3 years; MSc with at least 5 years or BSc with at least 8 years of experience in pharmaceutical or related fields.
• Experience in aerosol sciences preferred.
• Must possess broad analytical chemistry knowledge in HPLC, GC, UV, FTIR and other related analytical technologies and/or broad knowledge of development and manufacturing of MDI/DPI/Nasal products.
• Knowledge and understanding of FDA cGMP requirements as they apply to the Pharmaceutical industry. Good understanding of USP methodologies and ICH
• Strong English language skills including writing ability and oral communication.

Job Title:      Senior Principal Scientist

Site:                Miami, Florida

Function:      CMC

Department: Transpire Bio

Essential Duties and Responsibilities

• Supervise standard and advanced laboratory activities including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
• Introduce new concepts, products, equipment or processes to develop new applications. Develop technical solutions to complex problems which require the regular use of ingenuity and creativity.
• Evaluate and introduce new technologies to improve productivity and efficiency; be capable of generating new practical ideas and apply broad knowledge of related disciplines; drive continuous process improvement.
• Conduct complex formulation experiments to test, prove or modify applications based on applied research.
• Design and develop manufacturing processes and conduct manufacturing activities for inhalation drug products.
• Provide expert support for analytical and/or manufacturing related technical issues, analyzing data, identifying solutions, and implementing recommendations.
• Knowledge of legal and patent requirements as they pertain to product development.
• Write regulatory submission modules and any other documents to support submission and product approval.
• Develop statistical design of experiments and analyze/evaluate results.
• Perform structure elucidation on unknown impurities. Provide possible formation pathways for degradation impurities and recommend preventive solutions.
• Develop and implement appropriate training programs for analytical or manufacturing activities across all respiratory development sites.
• Mentor and assist junior scientists.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers.
• Work and communicate effectively with other functional groups and across global inhalation R&D sites. Present development activities, findings and recommendations to global teams and management.
• Lead internal/external projects on specific CMC topics, independently and within a team environment.
• Proactively contribute to innovative ideas and generation of innovative opportunities
• Proactively influence decisions on CMC
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs; follow Corporate safety rules and procedures.
• Comply with all Corporate guidelines and policies.

Qualification Requirements

• PhD in Chemistry or Pharmacy or related fields with at least 15 years; MSc with at least 17 years or BSc with at least 20 years of experience in pharmaceutical or related fields.
• Extensive knowledge of analytical techniques including HPLC, GC, UV, FTIR and/or extensive knowledge of development and manufacturing activities for MDI/DPI/Nasal products.
• Experience leading multifunctional project teams and able to multi-task effectively.
• Knowledge and detailed understanding of global regulatory requirements as applied to Respiratory or Nasal delivery. Good understanding of USP methodologies and ICH Extensive knowledge of FDA and cGMP requirements as they apply to the Pharmaceutical industry.
• Strong English language skills including writing ability and oral communication.

Job Title:      Senior Scientist II

Site:                Miami, Florida

Function:      CMC

Department: Transpire Bio

Essential Duties and Responsibilities

• Supervise standard and advanced laboratory activities including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
• Design, develop and supervise the execution of approved method transfer protocols, development and validation of all analytical methods.
• Write protocols, reports, methods and standard operation procedures
• Write regulatory submission modules and any other documents to support submission and product approval.
• Develop statistical design of experiments with minimal supervision.
• Independently design and develop manufacturing processes and conduct manufacturing activities for inhalation drug products.
• Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design.
• Provide expert support for analytical and/or manufacturing related technical issues.
• Develop and implement appropriate training programs for analytical or manufacturing activities across all respiratory development sites.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers.
• Work and communicate effectively with other functional groups and across global respiratory R&D sites.
• Independently lead major project tasks.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs or STPs; follow Corporate Health & Safety rules and procedures.
• Comply with all Corporate guidelines and policies.

Qualification Requirements

• PhD in Chemistry or Pharmacy or related fields with at least 9 years; MSc with at least 11 years or BSc with at least 14 years of experience in pharmaceutical or related fields.
• Broad knowledge of analytical techniques including HPLC, GC, UV, FTIR and/or broad knowledge of development and manufacturing activities for inhalation products.
• Knowledge and detailed understanding of global regulatory requirements as applied to Respiratory or Nasal delivery. Good understanding of USP methodologies and ICH Deep knowledge of FDA cGMP requirements as they apply to the Pharmaceutical industry.
• Strong English language skills including writing ability and oral communication

Job Title:      Sr. Scientist I

Site:                Weston, Florida

Function:      CMC

Department: Transpire Bio

Essential Duties and Responsibilities

• Conduct standard and advanced laboratory activities independently including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
• Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting; research and recommend corrective actions for out-of-specification and out-of-trend results.
• Execute approved method transfer protocols, develop and validate analytical methods
• Prepare and maintain accurate records in lab notebooks of all testing performed.
• Analyze data, identify trends and perform statistical analysis.
• Write protocols, methods, standard operation procedures, and submission documents independently. Design experimental studies and write reports with minimal supervision.
• Independently conduct manufacturing activities for inhalation drug products.
• Support the evaluation and introduction of new technologies; be capable of generating new practical ideas; possess good understanding of experimental design.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers. Work and communicate effectively with other functional groups. Lead broad project tasks effectively, with minimal supervision.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs & STPs; follow Corporate Health & Safety rules and procedures.
• Comply with all Corporate guidelines and policies.

Qualification Requirements

• PhD in Chemistry or Pharmacy or related fields with at least 6 years; MSc with at least 8 years or BSc with at least 11 years of experience in pharmaceutical or related fields.
• Experience in aerosol sciences preferred.
• Must possess broad analytical chemistry knowledge in HPLC, GC, UV, FTIR and other related analytical technologies and/or broad knowledge of development and manufacturing of inhalation drug products.
• Knowledge and broad understanding of FDA cGMP requirements as they apply to the Pharmaceutical industry. Good understanding of USP methodologies and ICH

Strong English language skills including writing ability and oral communication

Job Title:         Senior Scientist 1 to Principal Scientist, Formulations, Orally Inhaled and Nasal Products (OINDPs)

Job Level:       

Location:        Weston, FL (near Miami and Fort Lauderdale, Florida (FL))

Function:        R&D, Product Development

Reports to:     Chief Scientific Officer (CSO)

Job Specific Information

Summary

Independently conducts, leads and supervises standard and advanced laboratory activities including evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for Orally Inhaled and Nasal Drug Products (OINDPs) following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines. Leads the development and evaluation of new formulation technologies where required. Initiates investigations, data reviews and coaches and trains junior scientific staff.

Essential Duties and Responsibilities

• Independently conduct, lead and supervise standard and advanced laboratory activities for the development of OINDP formulations following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines.
• Independently design and lead pre-formulation, formulation and process development studies to recommend selection of APIs, excipients, packaging material and manufacturing process.
• Independently design and develop manufacturing processes and conduct manufacturing activities for OINDP products.
• Possess good understanding of other inhalation technologies.
• Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design.
• Provide expert support for manufacturing related technical issues.
• Write protocols, reports, methods and standard operation procedures.
• Write regulatory submission modules and any other documents to support submission and product approval.
• Develop statistical design of experiments with minimal supervision.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with Transpire Bio and Transpire Bio partner companies’ team members.
• Work and communicate effectively with other functional groups and across global respiratory R&D sites.
• Independently lead major project tasks.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs; follow Transpire Bio safety rules and procedures.
• Comply with all Transpire Bio Corporate guidelines and policies.

Qualification Requirements

• D., in Pharmaceutical Sciences or related discipline with 6 to 12 years, MS with 12+years research experience in pharmaceutical or related field.
• Must possess expert knowledge of development orally inhaled and nasal products (OINDPs).
• Knowledge of manufacturing processes of OINDP products is a plus.
• Knowledge and in-depth understanding of global regulatory requirements as applied to OINDPs.
• Excellent understanding of USP methodologies and ICH Deep knowledge of the FDA cGMP requirements as they apply to the pharmaceutical industry.
• Strong English language skills including writing ability and oral communication. Experience with writing of chemistry, manufacturing and control (CMC) sections of US and EU regulatory documents (NDA, ANDA, IND, IMPD).