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Director, Process Chemistry

Waltham, MA 02459

Posted: 04/06/2022 Industry: Scientific and Life Sciences Job Number: 14222

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: Director, Process Chemistry

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: Perm
  • Pay rate: $190K
  • Job Location: Waltham, MA
  • Job#: bh 14222

 

Director, Process Chemistry


Summary: The Director, Process Chemistry will be responsible for the development and execution of robust, well-understood processes and timely manufacture of cGMP materials. This will involve the rapid design of scalable syntheses and isolations, in conjunction with the identification of key process parameters, relevant process controls, the origin of impurities, and the appropriate process controls. Effectively lead the process chemistry staff on chemistry and career development through leadership, personal development, goal setting and ensure training on technical and scientific topics.

 

The Director, Process Chemistry has a broad understanding of process chemistry and analytical development, and a proven track record of solving complex technical and scientific issues. Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent leadership, communication, and collaboration skills in a cross-functional, multi-faceted environment; as well as a proven ability to achieve results in a virtual setting with external laboratories and manufacturing facilities are a must.

 

 

 

Responsibilities:

  • Responsible for process development and manufacture of drug substances under cGMP conditions
  • Responsible for vendor management, including vendor selection, technology transfer, and cGMP API manufacturing
  • Manage process development teams (internal and external) that develop new and/or enhance existing processes
  • Responsible for contracting SOWs and for negotiating price discounts
  • CMC author and reviewer of relevant regulatory submissions (e.g., IND, IMPD, DSUR, NDA…)
  • Lead CMC development teams and represent CMC on cross-functional program teams
  • Collaborate with Drug Product and Analytical Development to define and execute development strategies that enable phase appropriate deliverables
  • Effectively summarize key information such as program progress, timeline updates, and risk/opportunity assessments for periodic presentation to CMC group and management
  • Lead scenario planning to proactively provide analysis and recommendations on alternative development plans, along with associated assumptions and risks
  • Lead investigations to identify root cause, and approve CAPA for manufacturing deviations
  • Create and optimize development quality systems & Standard Operating Procedures in a team environment
  • Review/approve of CMC documents during due diligence exercise, and source documents for regulatory filings
  • Work with Business Development to facilitate partnering processes, build relationships and facilitate due diligent activities for various programs
  • Provide guidance and growth opportunities for process chemistry team members within CMC function
  • Work closely with Program Team and Finance to ensure that budgets are managed and communicated effectively

 

Qualifications:

  • Advanced degree in Organic Chemistry, or related field, Ph.D. preferred
  • 10+ years of relevant pharmaceutical process chemistry and GMP development and experience in the pharmaceutical industry, drug product development experience is preferred
  • Strategic view and leadership abilities as well as hands-on problem-solving skills and strong critical thinking
  • Proven experience as a direct manager of people and/or manager of external teams
  • Excellent verbal and written communication skills, ability to effectively work across levels, functions and companies with travel as needed (up to 10%)
  • Strong knowledge of modern synthetic organic chemistry and drug development processes
  • Experience in cGMP manufacturing and in supporting regulatory submissions
  • Experience working with all levels of management and consulting with key stakeholders. An ability to influence others for greater outcomes
  • The ability to perform under pressure, manage outsourced projects with external vendors, and work effectively in a fast-paced environment
  • Working knowledge of regulatory guidelines
  • Strong team player with strong innovation and solution-based skills
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors

 

 

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

 

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