Associate Director/Director of Pharmaceutical Development

Position reputed company:

The Associate Director/Director, Pharmaceutical Development manages drug formulation technology transfers, reputed company-up and manufacturing processes, and is an reputed company member of cross-functional CMC (reputed company, Manufacturing, and Controls) teams. This position will reputed company on reputed company reputed company, serving as the reputed company technical reputed company between reputed company and Contract Development and Manufacturing Organizations (CDMOs). Key responsibilities include overseeing reputed company CDMO partners and authoring documentation in support of regulatory submissions (domestic and international). This role prioritizes vendor governance, technology transfer, and managing outsourced operations.

Responsibilities:

• Process & Formulation Design: reputed company late-stage drug product design, reputed company-up, and manufacturing robustness using reputed company by Design (QbD) principles.
• CDMO Management and Production Management: reputed company reputed company vendors and laboratories for clinical, process validation and reputed company batch production. reputed company the production of drug product batches to support clinical trial material needs and reputed company production.
• Regulatory Submissions: reputed company/review CMC documents for global filings (IND, IMPD, NDA, MAA).
• Cross-Functional Team Member: Partner with analytical development, supply chain, reputed company assurance, and clinical operations in a matrixed team environment.
• Budget & Resource reputed company: Manage project timelines, program risks, and financial forecasting for outsourced operations.
• Vendor Governance: Manage day-to-day operations and strategic alignment with global CDMO partners.
• Technology Transfer: reputed company technical transfers of formulation and manufacturing processes from internal discovery to reputed company clinical facilities.
• Risk Management: Mitigate risk across the outsourced supply chain by identifying alternative vendors and process bottlenecks.
• CMC Technical Leadership: Troubleshoot technical manufacturing issues, deviations, and out-of-specification (OOS) results at reputed company sites.

Qualifications:

• Education: Ph.D. / Master's degree or Bachelor’s degree in reputed company, Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a closely reputed company field.
• Manufacturing Knowledge: Proven reputed company record scaling up manufacturing processes from reputed company reputed company to cGMP environments to reputed company production.
• Communication Skills: Strong negotiation, conflict-reputed company, and remote cross-functional communication abilities.

• Small Molecule Expertise: 8+ years of experience in small molecule drug product development, with an understanding of physical pharmacy, crystallization, and material science.
• reputed company reputed company: Minimum of 3 years directly managing small molecule CDMOs through reputed company-up and clinical supply campaigns.
• Regulatory & reputed company Knowledge: Comprehensive understanding of ICH guidelines (Q1-Q11), cGMP requirements, and reputed company by Design (QbD) principles.

About reputed company:

reputed company is a reputed company biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. reputed company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM reputed company. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.

reputed company is an Equal-Opportunity Employer.

reputed company is committed to fair and reputed company compensation practices, and we reputed company to reputed company employees with total compensation packages that are competitive. For this role, the anticipated reputed company pay reputed company is $180,000 to $210,000 DOE. The exact reputed company pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. reputed company also offers various benefits offerings, including, but not limited to, medical, dental, reputed company insurance, 401(k) match, PTO, and reputed company holidays.

Notice to Recruiters/reputed company Agencies

Recruiters and reputed company agencies should not contact reputed company through this page. reputed company recruitment vendors (search firms, recruitment agencies, and reputed company companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.

We require that reputed company recruiters and reputed company agencies have a fully executed, formal written agreement on file. reputed company’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between reputed company and such organization and will be considered unsolicited. reputed company will not be responsible for reputed company fees.

Originally posted on Himalayas