Contract Manufacturing Site Manager - TekWissen ® : Job Details

Position: Contract Manufacturing Site Manager

Location: Foster City, CA 94404

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Hybrid

Pay Rate: $85.00-85.00/Hr

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Job Description:

• Responsible within Global External Manufacturing to support the oversight of client Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs.
• Proactively and effectively work with other client functions (Quality Assurance, Quality Control, Strategic Sourcing, Supply Chain, Regulatory, Portfolio Management) to execute on manufacturing strategy.
• Executes the regular, tactical management of CMOs to ensure client's products are manufactured in accordance with the registered process and approved Master Production Record
• Enables timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control
• Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability.

Required Years of Experience:

• 15+

Top 3 Required Skill Sets:

• GMP Manufacturing expertise in commercial Biologics Drug Substance, Communication (written and verbal), Decision making (prioritization, risk evaluation)

Top 3 Nice to Have Skill Sets:

• Drug Product expertise, Technology Transfers, Clinical product manufacturing

Unique Selling Point of this role:

• Highly impactful role contributing to the advancement of innovative and transformative therapies.

Required Degree or Certification

• 4 year college (BS/BA in Science field)

Disqualifiers

• Must be flexible with work hours to support global network, either early morning (7 am) or evening (6pm) calls are frequent.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.