Drug Product SME

Base pay range

$61.00/hr - $61.00/hr

PLEASE NOTE THIS ROLE WILL BE 30 HOURS A WEEK

• Deliver drug product deliverables including formulation, manufacturing process, phase‑appropriate stability and GMP CTM manufacturing, regulatory document authoring/review, and tech transfer assigned to EACD. Implements innovation strategies that enhance scientific and business value of the Dept and extend its scope of influence within BI.
• Develop appropriate external capabilities (using partners accessed from academic, CRO, CMO, drug delivery and consultant constituencies) that allow virtual provision of drug product, drug delivery technology, etc for NCEs and NCE‑like projects.
• Introduce new practices and technologies and lead project/technology transfer to late Development, Operations. Provision of DS/DP supplies and appropriate GxP documentation, supplementary scientific information, for NCEs and ATMPs projects assigned to EACD.
• Ensure compliance with all required training, safety, regulatory, HR, laboratory notebook, intellectual property, GMP’s and GLP’s (where applicable), and corporate ethics and policies.

• Experienced in preclinical formulation, pre‑formulation characterization, formulation and process development (QbD), tech transfer, and cGMP manufacturing. Experience in oligonucleotide formulation and process development is a plus.
• Experienced in developing phase‑appropriate drug product and manufacturing clinical supply for NEC and/or oligonucleotides.
• Experienced in authoring and reviewing regulatory documents (IND, IMPD, NDA, etc.) and addressing questions from health authorities.
• Involvement in managing projects with external CROs and CDMOs/CMOs, building partner relationships with CDMOs/CMOs and external vendors. Proven ability to indirectly/directly manage, lead, and motivate others.
• Experience managing and directing teams/vendors in process research/development, drug product formulations and clinical GMP CTM manufacturing. Experience working effectively in cross‑functional teams comprised of internal and/or external contacts.
• Demonstrated ability to review and approve GxP documentation and technical reports.
• Experience authoring publications and delivering oral presentations to both scientists (internally and externally) and senior level management.
• Working knowledge of ICH quality guidance, EU and FDA drug manufacturing regulations as related to drug substance.
• Excellent written and oral communication and negotiating skills.
• Ability to work a flexible work schedule to accommodate program priorities and international activities as needed.
• Ability to travel (domestic and international) for business reasons (20‑30%).
• Onsite/Flex*:
  This position is site based with flexibility for remote working. Working onsite a minimum of 2‑3 days per week is required. Remote working norms will be clarified during the interview process.

• Master's Degree (e.g., MSc) or equivalent in chemistry, chemical engineering, or pharmaceutical sciences from an accredited institution, with ten‑plus (10+) years of industrial experience; OR
• Ph.D. degree in chemistry, chemical engineering, or pharmaceutical sciences from an accredited institution with seven‑plus (7+) years of industrial experience in the aspects of drug product development (ie: pre‑formation, formulation/process development, and manufacturing)

Seniority level:
Not Applicable

Employment type:

Contract

Job function:
Sales and Business Development

Industries:
Pharmaceutical Manufacturing