Associate Director, Process Chemistry Job at HireMinds, Newark, CA

eU0wbHZCYkQzWFpmNWNISng4S0pERkNwRHc9PQ==
  • HireMinds
  • Newark, CA

Job Description

Associate Director, Process Chemistry & API Development

Location: California (East Bay)

On-site commitment: 4 days a week

HireMinds is partnered with a biotech company focused on peptide and small molecule drug development, within reach of bringing commercial products to market. We are seeking your expertise in Process Chemistry and API process development to support peptide and small molecule drug development with our client. To be successful in this role you will be responsible for peptide process research, large-scale laboratory production, and related technology transfer to CDMOs, as well as managing successful partnerships with these CDMOs. You will provide an on-site and hands-on presence in collaboration with the R&D, Analytical, Manufacturing, and Clinical teams to deliver API parts of projects in this on-site work culture environment.

Your Responsibilities:

  • Analyze medicinal chemistry procedures to identify routes for efficient and scalable manufacturing of peptides and amino acids using both solid- and solution-phase peptide synthesis; communicate results clearly to internal and external teams.
  • Develop and execute manufacturing and supply strategies for raw materials, regulatory starting materials, and drug substances that meet global regulatory expectations.
  • Collaborate with multiple CDMOs to source amino acids and peptide fragments for large-scale API manufacturing; effectively manage outsourced process R&D and production activities.
  • Lead the evaluation and selection of new third-party contractors and suppliers globally for process development and manufacturing activities.
  • Work closely with analytical scientists to monitor and understand the impact of process changes on yield and impurity profiles during the development of peptide APIs.
  • Interface between analytical and toxicology departments to identify and qualify impurities.
  • Contribute to quality and CMC-related regulatory correspondence.
  • Stay current with the latest scientific literature related to peptide and process R&D.
  • Effectively document laboratory and scale-up activities.
  • Act as a creative and innovative problem-solver with a hands-on approach to resolving issues when needed.

You'll Bring:

  • PhD in organic/peptide chemistry with 7+ years, or MS in organic/peptide synthesis with 10+ years, industry pharmaceutical, biotech, or contract lab process chemistry experience.
  • Experience with process performance qualification and early commercial manufacturing is preferred.
  • Knowledge of QbD principles including DoE methodology applied to process development.
  • Strong understanding of FDA/ICH/cGMP guidance.
  • Proven ability to effectively lead projects with internal and external resources.
  • Experience with regulatory CMC filings (IND, NDA, IMPD, PAS) across all phases of pre-clinical and clinical development in both the U.S. and global markets. Familiarity with FDA and EMA regulations, and ability to work within regulatory agency requirements.
  • Strategic thinker and problem-solver capable of identifying risks and developing mitigation strategies.
  • Strong teamwork abilities related to negotiation and influencing skills.
  • Ability to adhere to strict project timelines and budgets, and advise teams and management on project impacts and changes.
  • Ability to commute and work on-site 4 days a week and participate in an on-site culture in a growing biotech team.

Compensation:

Salary: $175,000 to $190,000

Bonus: 10-15%

Stock considerations, health, dental, and 401k plan

Job Tags

Contract work, For contractors,

Similar Jobs

FlexTek

Operations Manager Job at FlexTek

 ...Description - Operations Manager (Air Cargo Facility) Our client is a global aviation organization that provides air carriers and airports with a wide range of aircraft, passenger, and cargo services to ensure the safe and efficient movement of freight and packages.... 

SearchPointNY

Marketing Content Coordinator Job at SearchPointNY

 ...Actively seeking a Legal Marketing & Content Strategy Coordinator for a FULL TIME & Hybrid Role . The position is fit for a candidate who has 2+ years of Marketing & Content related experience, preferably with experience within a Law or Professional Services Firm... 

TBG | The Bachrach Group

Recruitment Assistant Job at TBG | The Bachrach Group

 ...provide all the training you need to succeed. What Youll Do : Search for resumes and potential candidates using job boards and online tools. Organize and maintain candidate information in our systems. Match resumes to open roles and share qualified candidates... 

Phyton Talent Advisors

Bookkeeper Job at Phyton Talent Advisors

The ideal candidate will be well organized and comfortable dealing with financial data. This individual will be responsible for overseeing the accounts payable and receivable, processing payroll and conducting other tasks related to finance. This is an in-office opportunity...

Aequor

Special Education Teacher Job at Aequor

 ...identifying and implementing interventions for students through the Student Study Team process Maintain accurate student data for grading systems and IEP goal monitoring Attend professional meetings, educational conferences, and training workshops to enhance...