Chemical Development, Associate Director
Remote, MA 02110 US
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Title: Chemical Development, Associate Director
Hiring Organization: Connexion Systems & Engineering
- Duration: Perm
- Pay rate: $160-175K
- Job Location: remote
- Job# 14797
Seeking a highly motivated professional with experience in cGMP API process chemistry to join the CMC group. This position will be responsible for managing the drug substance process development and manufacturing activities. This position will be an integral part of the company’s effort to develop exciting first-in-class molecules targeting CNS afflictions, including psychosis. This is a unique opportunity to work with a well-funded and proven leadership team in a rapidly growing company.
- Manage synthetic process development activities and API scale-up for key programs. Critically analyze process and analytical data to identify and resolve key challenges during API development. Deliver APIs in a timely and cost-effective manner.
- Assist in management of CMOs to ensure delivery of scalable cGMP processes and high-quality cGMP APIs. Develop relationships with external parties (CROs, CMOs, RM suppliers, consultants, etc.) and stay current on industry trends and practices.
- Draft drug substance sections for regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers).
- Participate in the selection, evaluation and approval of new third-party contractors and suppliers for drug substance development activities (as needed).
- Identify and mitigate potential regulatory and quality risks for the drug substance manufacture and subsequent resolution of compliance and quality issues.
- Ensure adequate documentation processes and systems are available and followed for drug substance synthesis, testing and release (SOPs / Protocols review /approval).
- Must hold a minimum of 8 years relevant work experience with a PhD in organic synthesis or a minimum of 10 years relevant work experience with a Bachelors/Masters degree.
- Experience working with small molecule process development particularly in greater than 50 kg scale chemical development, tech transfer and manufacturing of registration batches. Late-stage experience highly preferred.
- Process development, technology transfer, and process troubleshooting experience with a strong record of problem solving is preferred.
- Strong knowledge of applied analytical methodology relating to in-process controls, drug substance release testing and stability assessment.
- Ability to effectively organize and prioritize tasks to achieve established deadlines.
- Knowledge of cGMPs, ICH guidelines, FDA and EMA/CHMP (and other international) regulatory requirements.
- 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 the ability to manage multiple projects and identify and resolve issues.
- Broad experience in an emerging, publicly traded company environment is a plus.
The successful candidate will also embody our values:
Our purpose is to create value for those we have the privilege to serve:
- We take pride in our work
- We keep our promises and deliver
- We are driven to meaningfully innovate
- We succeed through inclusion and teamwork
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