What are the responsibilities and job description for the Process Project Lead position at CORDEN PHARMA BOULDER INC?
Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.
CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
JOB SUMMARY:
Guide, direct, and review work done by the group to ensure an exceptional level of project performance, including leading a team of chemists to build processes to improve efficiency.
- Responsible and accountable for all aspects of project performance for demonstration batches within their group, including meeting technical, timeline, and budgetary objectives, by devising comprehensive plans and efficiently coordinating team efforts.
- Ensure experimental plans are designed to ensure project objectives are met, including high volume screening of crystallization conditions to develop innovative process improvement strategies.
- Take lead in customer and interdepartmental communications, or delegate to sufficiently trained and competent group members to enable seamless technology transfers of updated processes to sister sites, and provide training for updated methods, facilitating successful implementation, and minimizing transfer issues.
- Enforce compliant working practices, including completion of all required training, attendance at scheduled safety meetings, and performance of safe operating practices in the labs, production areas, and office areas by working with EH&S engineers to eliminate hazardous solvents on major projects.
- Manage performance of group members according to company standards and job descriptions for junior chemists by guiding them through complex experiments, empowering them to take ownership of key developmental steps, accelerating their growth, and ensuring successful project outcomes.
- Promote professional development, recruiting, hiring, and promotions for the members of the group, consistent on-the-job training for new technical personnel in operating diverse lab equipment such as EasyMax, NMR and Crystal 16 using analytical techniques like HPLC, GC, and KF.
- Apply principles of Continuous Improvement to ensure work processes and business processes are meeting business and client needs, including the development of chromatography free processes that reduce solvent usage significantly.
Position supervises 2 Distinguished Scientists, 1 Principal Process Chemist, and 2 Senior Process Chemists.
JOB REQUIREMENTS:
Requires a Ph.D. OR Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field and related experience (4 years with a Ph.D. OR 6 years with a Master’s).
Must have some experience in each of the following skills:
- API process development within CDMO settings, with experience in scaling processes from gram to 100 kilogram per batch GMP-compliant manufacturing with unit operations including solid-phase peptide synthesis and in process isolation (crystallization, precipitation, and lyophilization) in both lab and pilot plant scale;
- Synthetic organic chemistry and process design for highly functionalized small molecules including high-potent intermediate/API handling, air- and moisture-sensitive reactions, transition metal catalyzed coupling, troubleshooting process issues, and optimizing methodologies for impurity control and regulatory compliance;
- Leading risk assessment discussions (e.g., FMEA, nitrosamine risk assessment, and process control strategy development) to support regulatory filings such as FDA and ICH submissions using electronic tools like iRisk, generating structured justification for critical quality attributes (CQAs) and critical process parameters (CPPs);
- Implements PAT and DoE methodologies to optimize process conditions and improve batch reproducibility in automated lab platforms (e.g., EasyMax workstations, peptide synthesizers, high-/mid-throughput screening platforms, and flash chromatography);
- Designing experiments, conducting analysis and interpreting results using modern analytical tools such as LC, GC, MS, 1D/2D NMR, IR, and thermal analysis (DSC/TGA); and
- Leads multi-functional teams in technology transfer to GMP manufacturing sites, manages and mentors chemists and engineers, regularly engages clients, QA, and regulatory teams to align project goals and ensure compliance with global regulatory expectations.
Actual pay will be based on your skills and experience.
BENEFITS- 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
- Accident Plan
- Critical Illness Insurance
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Flexible Spending Account
- Health Insurance PPO/HSA
- Hospital Indemnity Plan
- ID Theft Protection
- Life Insurance
- Paid Maternity/Paternity Leave
- Tuition Reimbursement
- Wellness Program
- Vacation – Three Weeks 1st Year
- Vision Insurance
This posting will expire on November 14, 2025