Head of Formulation- Solid Formulations

3 weeks ago

Weston, United States Transpire Bio Full time

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 solids formulations including conventional and engineered dry powder inhalers (DPIs) 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 solids formulations including conventional and engineered dry powder inhalers (DPIs) 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 solid formulations including DPI 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.

• Routinely provide feedback on the performance of junior staff to management.

• 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

• Ph.D., in Pharmaceutical Sciences, Pharmaceutics, Material Sciences, Chemistry, Chemical Engineering 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 and manufacturing of solid formulations including conventional and engineered DPI products.

• Knowledge and in-depth understanding of global regulatory requirements as applied to orally inhaled and nasal products (OINDPs).

• Must possess knowledge of manufacturing processes for solid formulations including conventional and engineered DPI products.

• Knowledge and in-depth understanding of global regulatory requirements as applied to formulation and process development.

• Excellent understanding of USP methodologies and ICH guidelines. 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).

  • Pharmaceutical Manufacturing Process Technician

    1 month ago

    Weston, United States Transpire Bio Full time

    SummaryConducts laboratory activities including formulation and manufacturing process development, manufacturing process scale-up and process transfer activities across equipment, manufacturing scales and sites. Conducts manufacture of lab scale R&D, pilot scale, pivotal scale and commercial scale batches. Contribute towards installation, maintenance and...

  • Pharmaceutical Manufacturing Process Technician

    1 month ago

    Weston, United States Transpire Bio Full time

    SummaryConducts laboratory activities including formulation and manufacturing process development, manufacturing process scale-up and process transfer activities across equipment, manufacturing scales and sites. Conducts manufacture of lab scale R&D, pilot scale, pivotal scale and commercial scale batches. Contribute towards installation, maintenance and...

  • Director, Analytical Development/Analytical Sciences

    1 month ago

    Weston, United States Transpire Bio Full time

    SummaryProvides subject matter expertise on all topics Analytical Sciences. Provides scientific and technical leadership in identification, selection and implementation of analytical techniques that may be suitable for the portfolio of projects. Develops and oversees strategies for development, verification, optimization, transfer, and validation of stage...

  • Director, Analytical Development/Analytical Sciences

    1 month ago

    Weston, United States Transpire Bio Full time

    SummaryProvides subject matter expertise on all topics Analytical Sciences. Provides scientific and technical leadership in identification, selection and implementation of analytical techniques that may be suitable for the portfolio of projects. Develops and oversees strategies for development, verification, optimization, transfer, and validation of stage...

  • Operating Room Nurse

    4 weeks ago

    Weston, United States Amsurg Corp Full time

    Job Title: Operating Room NurseWe are seeking a highly skilled and experienced Operating Room Nurse to join our team at Amsurg Corp. As an Operating Room Nurse, you will be responsible for providing high-quality patient care in a fast-paced and dynamic environment.Responsibilities:Perform initial pre-op assessments and formulate appropriate plans of care for...

  • Operating Room Nurse

    1 month ago

    Weston, United States Amsurg Corp Full time

    Job Title: Operating Room NurseWe are seeking a highly skilled and experienced Operating Room Nurse to join our team at Amsurg Corp. As an Operating Room Nurse, you will be responsible for providing high-quality patient care in a fast-paced and dynamic environment.Responsibilities:Perform initial pre-op assessments and formulate appropriate plans of care for...

  • Operating Room Nurse

    2 weeks ago

    Weston, United States Amsurg Corp Full time

    Job Title: Operating Room Registered NurseWe are seeking a highly skilled and experienced Operating Room Registered Nurse to join our team at Amsurg Corp.Job Summary:The Operating Room Registered Nurse will be responsible for providing high-quality patient care in a fast-paced operating room environment. The ideal candidate will have a strong background in...

  • Associate Director, Government Pricing

    1 day ago

    Weston, United States Apotex Corp. Full time

    As Associate Director, Government Pricing, you will be responsible to lead the Pricing team in validation, calculation, and analytics to ensure compliance and integrity, along with insights to enable good business decisions. Responsible for maintaining compliance with all government pricing calculations and reporting along with interpretation of statutes,...

  • Associate Director, Government Pricing

    22 hours ago

    Weston, United States Apotex Corp. Full time

    As Associate Director, Government Pricing, you will be responsible to lead the Pricing team in validation, calculation, and analytics to ensure compliance and integrity, along with insights to enable good business decisions. Responsible for maintaining compliance with all government pricing calculations and reporting along with interpretation of statutes,...

  • Registered Nurse

    14 hours ago

    Weston, United States Ambulatory Surgery Center Full time

    Registered Nurse (Operating Room)We are currently searching for a Full Time OR Registered Nurse to work Mondays - Fridays who can work cooperatively with staff and physicians and perform a variety of tasks. Responsible for the knowledge of principles, theories and practices of the nursing process and the ability to deal efficiently and effectively with a...

  • Registered Nurse

    3 weeks ago

    Weston, United States Ambulatory Surgery Center Full time

    Registered Nurse (Operating Room) We are currently searching for a Full Time OR Registered Nurse to work Mondays - Fridays who can work cooperatively with staff and physicians and perform a variety of tasks. Responsible for the knowledge of principles, theories and practices of the nursing process and the ability to deal efficiently and effectively with a...

  • CRNA - Anesthesia Specialist

    1 month ago

    Weston, United States Cleveland Clinic in Florida - Weston Full time

    Job SummaryCleveland Clinic in Florida - Weston is seeking a skilled Certified Registered Nurse Anesthetist (CRNA) to join our team at Cleveland Clinic Weston Hospital. As a CRNA, you will play a vital role in providing high-quality patient care and working collaboratively with our multidisciplinary team.ResponsibilitiesPerform pre-anesthetic evaluations of...

  • Accounts Payable Director

    2 weeks ago

    Weston, United States Phoenix Pro Connect Full time

    Accounts Payable ManagerPhoenix Pro Connect is seeking an experienced Accounts Payable Manager to lead our financial operations team.Key Responsibilities:Direct and manage daily activities of the accounts payable department.Efficiently process high-volume transactions, handling over 2,000 bi-weekly invoices.Utilize and optimize the COR360 platform to ensure...

  • Tech Support Manager

    1 week ago

    Weston, Florida, United States UKG (Ultimate Kronos Group) Full time

    Job SummaryAs a Tech Support Manager at UKG, you will oversee the daily operations of our support center, aligning resources, projects, and training to ensure customer satisfaction. You will manage a team of Product Support Representatives, guiding them in providing exceptional customer product support and resolution in a fast-paced, high-volume...

  • Rehabilitation Registered Nurse

    3 weeks ago

    Weston, United States Amergis Full time

    Job Title: Rehabilitation Registered NurseAmergis is seeking a skilled and compassionate Rehabilitation Registered Nurse to join our team. As a Rehabilitation Registered Nurse, you will play a vital role in assisting patients in achieving and maintaining optimal function due to chronic illness and/or debilitating injury.Key Responsibilities:Assess the...

  • CRNA - Anesthesiologist - Florida

    2 months ago

    Weston, United States Cleveland Clinic in Florida - Weston Full time

    Job Summary:Cleveland Clinic in Florida - Weston is seeking a skilled Certified Registered Nurse Anesthetist (CRNA) to join our team of anesthesia professionals. As a CRNA at Cleveland Clinic, you will have the opportunity to work in a dynamic and collaborative environment, providing high-quality patient care and contributing to the success of our anesthesia...

  • Operating Room Nurse

    3 weeks ago

    Weston, United States Ambulatory Surgery Center Full time

    Job Title: Registered Nurse (Operating Room)We are seeking a highly skilled and experienced Registered Nurse to join our team at the Ambulatory Surgery Center. As a Registered Nurse in our Operating Room, you will play a critical role in providing high-quality patient care and ensuring a safe and efficient surgical experience.Responsibilities:Perform initial...

  • Certified Registered Nurse Anesthetist

    2 months ago

    Weston, United States Cleveland Clinic in Florida - Weston Full time

    Job Summary:Cleveland Clinic in Florida - Weston is seeking a highly skilled Certified Registered Nurse Anesthetist (CRNA) to join our team of anesthesia care providers. As a CRNA at Cleveland Clinic, you will have the opportunity to work in a dynamic and collaborative environment, providing high-quality patient care and contributing to the success of our...

  • Insurance Account Manager

    1 week ago

    Weston, United States Truist Full time

    Job SummaryAs a Personal Lines Account Manager at Truist, you will be responsible for building and maintaining key client and carrier relationships. This role requires excellent communication skills, a strong service orientation, and the ability to resolve client and company problems. You will also be responsible for leading the marketing of accounts,...

  • CRNA - Anesthesiologist Assistant - Weston Florida

    1 month ago

    Weston, United States Cleveland Clinic in Florida - Weston Full time

    Job Title: CRNA - Anesthesia Care ProviderWe are seeking a skilled Certified Registered Nurse Anesthetist (CRNA) to join our team at Cleveland Clinic Weston Hospital in Florida. As a CRNA, you will play a vital role in providing high-quality anesthesia care to our patients.Responsibilities:Perform pre-anesthetic evaluations of patients, write accurate notes...