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Manager/Sr. Manager, Pharmaceutical Mfg

Chicago, IL

Posted: 09/24/2020 Employment Type: Direct Hire Job Category: Clinical: Supplies/ Logistics Job Number: 2636

Job Description


The Manager/Sr. Manager, Pharmaceutical Manufacturing will ensure delivery of clinical / commercial drug product and support external operations at multiple contract manufacturing organizations (CMOs) / Clinical Service Providers (CSPs) organizations. This includes on-site person-in-plant oversight of manufacturing activities during tech transfers, scale-up, DOEs, QbD activities, and other manufacturing operations. Drive multiple projects at both clinical development and commercial manufacturing stages, including long-term sourcing and life-cycle programs.  Leverage technical skills (chemistry/engineering, GMP regulation, risk evaluations, drug development), business skills (project management, finance), and soft skills (vendor engagement, relationship building) to provide strategic input for program core teams and budgets.   Support colleagues on a routine basis; e.g., Product Development, Supply Chain, CMC, Quality Control, Quality Assurance, Regulatory.

Essential Job Functions:

Support manufacturing operations at Contract sites (CMOs, etc.). Responsibilities include, but may not be limited to:
  • Provide technical expertise in the areas of aseptic fill/finish and tech transfer of drug product
  • Responsible for a wide range of activities associated to the execution of clinical / commercial drug product manufacturing
  • Support and manage the day-to-day manufacturing activities to ensure drug product clinical / commercial supply
  • Direct interaction with contract site management, includes being on-site at CMOs and hands-on person-in-plant oversight activities at CMOs and CSPs
  • Technical review of Engineering and GMP batch records, validation protocols and reports, work instructions, SOPs, deviations, CAPAs, or other required documents for cGMP operations
  • Helps with logistics activities such as, proposals, quotes, invoices, and shipping
  • Frequently interacts with other functional peer group managers within company and CSPs/CMOs to support the development or manufacturing activities
  • Ability to effectively manage multiple priorities and have sound organizational / time management skills, and be detailed oriented
  • Strong negotiation and problem-solving skills and exceptional verbal, written and communication skills

Requirements / Qualifications:
  • Bachelor’ s/Master’ s degree required in relevant Life Sciences, Scientific, or Technical degree with 5 to 10 years of experience working with pharmaceuticals / biopharmaceuticals
  • Minimum 7 to 10 years of experience in a GMP pharmaceutical/biopharmaceutical environment with sterile drug product manufacturing
  • Experience with peptides, small molecules, biologicals, and aseptic processes
  • Demonstrated project management skills and ability to develop effective working relationships internally and with external sites
  • Self-directed, flexible, able to prioritize, multi-task, and work in a fast-paced environment
  • Must work well in cross-functional teams and be able to communicate effectively with external partners, peers, and managing third party CMO relationships
  • Strong communication skills (written and verbal), team player in a matrix environment, and proven negotiating and interpersonal skills, and the ability to clearly present recommendations
  • Must have strong computer skills, including all MS Office applications

Working Conditions:
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations.  Periodic overnight travel.
  • Travel may be required up to 25% at times to CMOs and CSPs locations.

 

Meet Your Recruiter

Tracey Goldthwaite
Senior Vice President

Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.

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