Be an early applicantLess than 25 applicants

Company

Original Job Post

BioSpace · 2 days ago

Senior Scientist I - Formulation Lead

Watertown, MA

Full-time

Onsite

Senior Level

4+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BiotechnologyCommunities

Comp. & Benefits

Insider Connection @BioSpace

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Lead process development, tech transfer and manufacturing scale-up activities of late stage small molecule drug products

Effectively interact with CDMOs to understand the product manufacturing requirements, the necessary equipment, facility, and process support technologies required from CDMO’s to conduct drug product development and manufacturing of products. Successfully lead the formulation and process development as well as manufacturing of clinical batches at the selected CDMO’s.

Successfully lead the process development as well as manufacturing of clinical batches at selected CDMO’s

Conduct process scale up and robustness studies according to a QbD setup (e.g. DoE) to support late stage and commercial manufacture

Conduct risk assessments/FMEAs through process development to DP process validation. Lead technical transfer of manufacturing process to commercial manufacturing site.

Identify key stake holders and work collaboratively with cross-functional CMC, commercial, quality, regulatory, project management, legal, sourcing, supply chain and other functions to meet project goals.

Author and answer on DP sections in regulatory submission documents and support global filings.

Author technical reports and present at various technical and management meetings.

Apply innovative approaches to streamline DP development activities and establish technical and business process flows/ guidelines to support portfolio and organization changes.

Train, mentor and guide colleagues and support employee development initiatives.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Formulation DevelopmentPediatric FormulationsProcess DevelopmentBCS Class II/IV CompoundsCommercial ManufacturingNDA/MAA AuthoringPharmaceutical PrinciplesEngineering PrinciplesProject ManagementFluent in EnglishRegulatory FilingsCMC SectionsMethod DevelopmentProblem-SolvingCommunicationTeam PlayerProactiveResourcefulFlexibleMultitaskingLeadership

Required

Ph.D. in Pharmaceutical Sciences or relevant technical field and 4+ years of productive, relevant work experience, or M.S. (or equivalent degree) and 8+ years of productive, relevant work experience. Minimum of 3+ years experience in managing development and manufacturing activities at CDMO's.

A proven track record in developing and scaling up formulations and process for oral administration from pre-IND through late-stage development and commercialization.

Expertise and direct knowledge in pediatric formulation development.

Experience in process development of poorly soluble (BCS Class II/IV) compounds (small molecules).

Extensive knowledge and hands-on experience with equipment and processes commonly used for solid and liquid oral formulation development.

Experience in large-scale commercial manufacturing and NDA/MAA authoring experience.

Sound knowledge of pharmaceutical and engineering principles in the solid dosage form development for both clinical and commercial scales.

Excellent project management and communication skills. Must thrive in a fast-paced complex, inter-disciplinary global organization while remaining flexible, proactive, resourceful and independently multitask. Fluent in oral and written English. Additionally, enjoy taking the lead while also being a valuable team player.

Experienced in writing, reviewing, and approving CMC sections of regulatory filings from early-stage development through commercial launch for global filings.

Experience in establishing new methods, systems and processes to improve department and product development approach.