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Process Development, Drug Product, CMC (Manager-Associate Director)

Remote, MA

Posted: 02/14/2023 Industry: Scientific and Life Sciences Job Number: 15338

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:  Process Development, Drug Product, CMC (Manager-Associate Director)
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
  • Duration: PERM
  • Job Location:  Remote (EST hours)
  • Job#: bh15338
Process Development, Drug Product, CMC (Manager-Associate Director)

Seeking an experienced and highly motivated Manager-Associate Director, Process Development, Drug Product 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 technology transfer, process development and associated manufacturing in the development of solid/liquid oral dosage forms for use in clinical studies, registration, and validation of drug product manufacturing. 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 late-stage technology transfer, and implementing and leading process development, scale-up, process optimization & manufacturing for current and future drug products.
  • Monitor and drive the tech transfer 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.
  • Being detail oriented, draft and review high quality manufacturing batch records, protocols and all associated technical documents in collaboration with applicable internal and external partners.
  • Develop and support robust manufacturing processes, and scale-up procedures for registration batches by applying QBD approaches as per FDA and EMA requirements.
  • Draft formulation development reports and relevant IND and NDA CMC sections, as well as annual CMC reports with respect to drug formulation and drug product production.
  • Collaborate effectively with various functions of CDMO technical operations, such as technical process development and analytical, to establish phase appropriate control strategy for manufacturing processes.
  • Support the selection, evaluation and approval of new third-party contractors and suppliers for drug product development activities (as needed).
  • Work collaboratively with quality, analytical, drug substance, regulatory, supply chain and project management teams to deliver appropriate drug products for Phase II and III human clinical trials as well as potential commercialization.
  • 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.
  • 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).
  • 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 10+ years of industry experience in oral drug formulation, or a minimum of 15+ 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 5 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.
  • In depth knowledge of analytical methodology required in cGMP manufacturing and release of clinical trial materials.
  • 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.
  • Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient.
  • 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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