Senior Director of Technical Services

4 weeks ago

Marcus Hook, United States Quotient Sciences Limited Full time

Quotient Sciences - Philadelphia, LLC

Senior Director of Technical Services

Boothwyn ,

Pennsylvania

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The Director of Technical Services is responsible for oversight of Commercial Product Technical Services including the management and support of new and existing pharmaceutical products and all internal and external deliverables related to the product commercialization. Job Responsibilities: Lead Technical Services team to support client needs, provide project updates, oversight, and act as a point of contact for executing day-to-day Commercial Manufacturing deliverables;

Establish priorities for the technical team to meet business needs; Apply management and leadership skills to align staff activities with departmental and site objectives; Execute functional business plans and contributes to the development of departmental and overall business strategies; Represent Technical Operations at the site leadership meetings; Work cross-functionally with Commercial Manufacturing, Quality Control, Quality Assurance, Formulation Development, and Facilities & Engineering to develop and maintain manufacturing processes that meet CGMP and business requirements; Manage professional technical teams capable of fulfilling the departmental objectives; Provide technical guidance for employees, colleagues, and clients; Coordinate the work of the technical team to identify and implement technology-driven productivity and cost improvements; Forecast resource needs and manage allocated budget as applicable; Support audits and interact with representatives from regulatory agencies; Create and approve new guidance, policies, and procedures to support process improvements; Develops and monitors performance plans and requirements for direct reports. Mentor direct reports to achieve and improve their performance for company and personal career growth; Support Technical transfer from internal project to the process validation group and commercial group; Will supervise 7 employees: (Process Engineer 2, Principal Technical Writer 1, Validation Engineer 2, Group Leaders 2 ).

Master's degree in Chemistry or related field, or foreign degree equivalent, plus nine (9) years of experience in the pharmaceutical industry of oral solid dosage form development and manufacturing. The experience (which may be gained concurrently) must include: 9 years of experience with Solid oral dosage form industry handling process development and product lifecycle management; 9 years of experience demonstrating thorough knowledge of quality by design principles for product and process development, knowledge of different regulatory requirements for process development and process validation; 5 years of experience managing the development or technical services teams delivering the product or process development deliverables; and Must have thorough knowledge of different regulatory guidance regarding process development, ICH guidelines, process validation, equipment facility and utility qualifications. Job Location: Quotient Sciences-Philadelphia, LLC. 3 Chelsea Parkway, Suite 305, Boothwyn, PA 19061 and 3080 McCann Farm Drive Garnet Valley, PA 19060. 40 hours per week, 8:30 am -- 5:00 pm. To apply, send resume and letter of application detailing experience to John Degnan, Associate Director, Talent Acquisition, People Function, Quotient Sciences-Philadelphia, LLC., john.degnan@quotientsciences.com.

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