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Formulation Development, Drug Product, CMC (Manager - Senior Manager)

Remote, MA

Posted: 02/14/2023 Industry: Scientific and Life Sciences Job Number: 15339

Job Description

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Title: Formulation Development, Drug Product, CMC
Hiring Organization: Connexion Systems & Engineering
  • Duration: Perm
  • Pay rate: $130-160k
  • Job Location: Remote
  • Job# 15339

Position Summary
Seeking an experienced and highly motivated Manager - Senior Manager, Formulation 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 early formulation development, development for Phase I, II and III as needed, technology transfer, process development and associated manufacturing in the development of solid/liquid oral dosage forms for use in clinical studies and future validation of drug product manufacturing processes.

  • This person approaches projects with the passion and belief that our dosage forms have the power to enhance patient lives and is primarily responsible for early-stage clinical formulation development, developing several enabling formulations and drug delivery systems.
  • Support formulation and manufacturing work for current and future drug products at CDMOs; needs to work effectively by providing technical oversight to ensure project timelines and technical deliverables are met.
  • As per portfolio needs, investigate formulation development approaches in early stages and understand processes to facilitate fast entry into humans.
  • Monitor and drive the tech transfer and execution of drug product development and cGMP manufacturing plans at external partners (CDMOs) with high quality.
  • Collaborate with all internal team members and external CDMOs, chemical development, analytical development, early-stage formulation research and other departments to develop a robust quality drug product.
  • 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.
  • Support robust manufacturing process, scale up procedures for registration batches by applying QBD approaches as per FDA 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.
  • Support the selection, evaluation and approval of new third-party contractors and suppliers for drug product development activities (as needed).
  • 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.
  • Work collaboratively with quality, analytical, drug substance, regulatory, supply chain and project management teams to deliver appropriate drug products for different phases of human studies.
  • 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 presentations and updates as necessary to management.
  • Ensure adequate documentation processes and systems are available and followed for drug product production, testing and release (SOPs / Protocols review /approval).
  • 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 7+ years of industry experience in drug formulation, or a minimum of 12+ years relevant work experience with a Master’s degree.
  • Strong knowledge of cGMP and QbD approaches to drug product development, including commonly used tools used for DOE studies.
  • Should be able to apply science and risk-based approach to drug development, thus ensuring delivery of quality drug products (CTMs).
  • The candidate must have sound understanding of material properties to develop a robust formulation in support of clinical trials and commercial, along with pre-formulation, reformulation and drug delivery experience.
  • Proven hands-on experience on equipment and manufacturing processes commonly used for solid and liquid oral formulation development.
  • Ability to work under pressure and deliver high quality clinical trial and manufacturing batches.
  • Proven experience with multiple oral formulation approaches, delayed, sustained release formulations and bioavailability enhancement is preferred.
  • Broad scientific knowledge and proven track record in applying understanding of pre-formulation, material science, pharmacokinetics, drug delivery and manufacturing processes for formulations administered orally and/or parenterally and associated technologies.
  • Proven success in managing and overseeing CDMOs.
  • In depth 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.
  • 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. Experience with nanoparticles, intramuscular injectables, and/or transdermal formulations would be an asset.
  • Strong knowledge of cGMP and QbD approaches to drug product development.
  • 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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