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SENIOR SITE MANAGER OF SMALL MOLECULES, CONTRACT MANUFACTURING ORGANIZATION
Job Field: Office Jobs
Location: United States, CA
Salary: $Not stated
Location: United States, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Job ID:00408608Job64of371Senior Site Manager of Small Molecules, Contract Manufacturing OrganizationSouth San Francisco, CaliforniaJob factsJob functionContract Manufacturing Drug Product ProductionLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionSr. Site Manager- Contract Manufacturing- Small Molecules Sr. Site Manager- Contract Manufacturing- Small Molecules Responsibilities: Lead cross-functional teams to select and manage contract manufacturing organizations (CMOs) in order to support Small Molecule drug substance and drug product programs for early stage clinical and potentially late stage clinical programs. Prepare Requests for Proposals, Statements of Work and negotiate agreements for clinical programs. Manage the activities and business aspects of the contract relationships with CMOs and participate on CMC teams as the manufacturing outsourcing team leader. Collaborate with CMC teams in scoping out clinical manufacturing programs for consideration for outsourcing to CMOs. Assist or lead in the development of new outsourcing strategies that we will apply to our business. Participate in Business Development Due Diligence activities for new technologies or new drug candidates and contribute to development of in-licensing supply agreements. Who You AreRequirements: BS in Life Sciences or related field is required. An advanced degree (MS, PhD or MBA) is also beneficial. 8+ years of experience in the biotech/pharmaceutical industry is required. Previous experience working with clinical development-stage and commercial pharmaceutical products along with overall knowledge of pharmaceutical development and clinical manufacturing and associated Regulatory, QA, and cGMP requirements is desired. The following competencies are essential in this role: strong leadership, decision-making/problem-solving, contract negotiation/administration and written/verbal communication. In addition candidates must have the ability to work effectively with cross functional, multi location & international teams. Demonstrated project management skills are required; strong financial management skills are a plus. This position may require extensive (25%) domestic and international travel. DIVISION: PTM Contract Mfg.
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<tr><td valign="top" width="450"><b>Job ID:00408608Job64of371Senior Site Manager of Small Molecules, Contract Manufacturing OrganizationSouth San Francisco, CaliforniaJob factsJob functionContract Manufacturing Drug Product ProductionLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionSr. Site Manager- Contract Manufacturing- Small Molecules Sr. Site Manager- Contract Manufacturing- Small Molecules Responsibilities: Lead cross-functional teams to select and manage contract manufacturing organizations (CMOs) in order to support Small Molecule drug substance and drug product programs for early stage clinical and potentially late stage clinical programs. Prepare Requests for Proposals, Statements of Work and negotiate agreements for clinical programs. Manage the activities and business aspects of the contract relationships with CMOs and participate on CMC teams as the manufacturing outsourcing team leader. Collaborate with CMC teams in scoping out clinical manufacturing programs for consideration for outsourcing to CMOs. Assist or lead in the development of new outsourcing strategies that we will apply to our business. Participate in Business Development Due Diligence activities for new technologies or new drug candidates and contribute to development of in-licensing supply agreements. Who You AreRequirements: BS in Life Sciences or related field is required. An advanced degree (MS, PhD or MBA) is also beneficial. 8+ years of experience in the biotech/pharmaceutical industry is required. Previous experience working with clinical development-stage and commercial pharmaceutical products along with overall knowledge of pharmaceutical development and clinical manufacturing and associated Regulatory, QA, and cGMP requirements is desired. The following competencies are essential in this role: strong leadership, decision-making/problem-solving, contract negotiation/administration and written/verbal communication. In addition candidates must have the ability to work effectively with cross functional, multi location & international teams. Demonstrated project management skills are required; strong financial management skills are a plus. This position may require extensive (25%) domestic and international travel. DIVISION: PTM Contract Mfg.
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