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Drug Product Commercial Manufacturing, CMC (Manager - Senior Manager)

Remote, MA

Posted: 02/15/2023 Industry: Scientific and Life Sciences Job Number: 15343

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title:  Manager-Senior Manager, Drug Product Commercial Manufacturing, CMC
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
  • Duration: PERM
  • Job Location:  Remote (EST)
  • Job#: bh15343
Manager-Senior Manager, Drug Product Commercial Manufacturing, CMC

Seeking an experienced and highly motivated Manager-Senior Manager, Drug Product Commercial Manufacturing, CMC with expertise in small molecule formulation to join the CMC group and to work on exciting first-in-class molecules targeting CNS afflictions, including psychosis. Reporting to the Director of Formulation Development, Drug Product, CMC & Preclinical Development, this position will play a critical role in supporting commercial drug product manufacturing for solid/liquid oral dosage forms. This is a unique opportunity to work with a well-funded and proven leadership team in a rapidly growing company.
  • This person is primarily responsible for supporting drug product commercial manufacturing to ensure robust process performance by using continuous process verification (CPV).
  • Implement and lead process development, scale-up, process optimization & manufacturing for current and future drug products.
  • Monitor and drive the tech transfer, process validation and execution of drug product development and cGMP manufacturing plans at external partners (CDMOs) with high quality; needs to think critically and work effectively by providing technical oversight to ensure project timelines and technical deliverables are met.
  • Provide technical support, review of batch records and analytical data oversight for Drug Products, ensuring compliance, which includes addressing deviations, identification for out-of-trend or out-of-specification results (OOT/OOS) investigations, performing root cause analyses and assigning appropriate root causes and corrective and preventive action (CAPA).
  • Support process manufacturing changes using formal change controls and annual reviews.
  • Is the technical lead for driving continuous improvement by performing process capability analysis to identify and execute process robustness improvement projects, developing process control strategy, and providing technical oversight of CDMO sites for all products in scope.
  • Support all regulatory activities and filings (INDs, IMPDs, NDAs, briefing packages, any other regulatory dossiers), including reviews of, and associated changes to, such documents, for assigned products and new products.
  • Represent Drug Product CMC group on project teams and work closely with product and process development team, Quality Assurance, Analytical, Regulatory, Drug Substance, Supply Chain, Quality Control, Project Management, and project team members in developing strategies and problem-solving efforts.
  • Effectively collaborate with project team members, CDMOs, RM suppliers and consultants as needed in accomplishing project goals and delivering quality drug product.
  • Participate in the selection, evaluation and approval of new third-party contractors/manufacturers and suppliers for drug product development activities as required.
  • Ensure adequate documentation processes and systems are available and followed for drug product production, testing and release (transfer documentation, technical memos, SOPs / Protocols review /approval, development reports, regulatory filings, change controls).
  • Collaborate with QA functions and associated functions to ensure implementation of highest possible quality standards throughout manufacturing and process development impacting drug products.
  • Support with timely DP presentations and technical updates as necessary to management.
  • Actively communicate, be proactive, collaborate with, and contribute to other functional areas to solve problems and achieve set goals in a timely manner.
  • Other duties as needed.

Required Qualifications
  • Ph.D. in pharmacy or pharmaceutics with 5+ years of industry experience in oral drug formulation, or a minimum of 10+ years relevant work experience with a Master’s degree.
  • Proven success in managing and overseeing CDMOs.
  • Experienced in late-stage program development, including registration, process validation and commercial product launch.
  • Broad scientific knowledge in formulation, material science and manufacturing processes for formulations administered orally.
  • Experience with multiple oral formulation approaches, and delayed and sustained release formulations. Working knowledge of extrusion spheronization is desirable.
  • Working knowledge of analytical methodology required in cGMP manufacturing and release of clinical trial materials.
  • Minimum of 3 years of experience in drafting formulation development reports and pharmacy manuals, as well as drug product sections of INDs, IMPDs, and NDAs.
  • Ability to work under pressure and deliver high quality clinical trial and manufacturing batches.
  • Experience in pharmaceutical technology, pharmaceutical process scale-up, technical transfer and manufacturing, and packaging/artwork support/activities is a plus.
  • In depth knowledge of analytical methodology required in cGMP manufacturing and release of clinical trial materials and commercial drug manufacturing.
  • Experience in drafting, reviewing, and approving required documentation pertaining to the development and preparation of drug products under cGMP environment. A proven track record of successful development of oral and non-oral dosage forms.
  • Strong knowledge of cGMP and QbD approaches to drug product development, including tools commonly used for DOE studies, is desirable.
  • Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient.
  • Demonstrated capability in using standard tools utilized for root cause analysis. Ability to close out investigations and issues at CMOs.
  • Understanding of statistical process analysis and control methods. Ability to use statistical software to analyze process-related data to establish process capability or for troubleshooting purposes.
  • Ability to travel, expected at <10-15%/year.
  • Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
  • Attention to detail and quality are critical to success.
  • Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
  • Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
  • Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
  • Forward thinking mindset with ability to manage multiple projects, identify and resolve issues.
  • Broad experience in an emerging, publicly traded company environment is a plus.

 Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you immediately.

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