Senior Director, Manufacturing and Analytical

Senior Director, Manufacturing and Analytical

This position is responsible for directing all aspects of CMC (Chemistry, Manufacturing and Controls) for pharmaceutical drugs and agents as well as the analytical work associated with that CMC across all of the small molecule projects within Pharma Cinq and, potentially, gene therapy projects. The responsibilities span the range of CMC from sourcing starting materials to formulation development, planning and managing manufacturing of API (active pharmaceutical ingredient) and potential drug products, as well as directing the associated analytical work. This position will also be responsible for the CMC sections of relevant regulatory (FDA and other) documents from INDs to NDAs. This position will work closely with senior management and will supervise the work of others directly and / or across interdisciplinary teams.

Duties and Responsibilities :

• Identifies and works with the most suitable manufacturers of API's
• Oversees and directs the transfer of manufacturing processes and analytical methods from any current or past vendors to the most suitable CDMOs for each drug candidate
• Identifies and works with the most suitable chemistry process development-improvement and scale-up laboratories
• Identifies and works with the most suitable formulation development labs
• Works within and / or leads project teams to accomplish project goals and manages / coordinates work of other team members
• Ensures that manufacturing processes, analytical methods and new formulations are and will meet FDA (and other) regulatory requirements, including GLP and GMP
• Acts as the primary interface with Quality Assurance on matters related to CMC and methods development and validation
• Manages and works with subject matter experts and consultants as needed
• Troubleshoots and optimizes manufacturing processes and analytical methods
• Writes CMC sections of INDs, NDAs, Prior Approval Supplements (PAS), Annual Reports and other FDA (and other regulatory authorities) documents and submissions
• Reviews CMC data and reports as well as other sections of INDs, NDAs, PAS, Annual Reports intended for submission to FDA and other regulatory agencies
• Prepares and / or supports preparation of invention disclosures and patent applications
• Presents progress, challenges, milestones, needs to senior management and makes recommendations
• Works cross functionally with other business units on projects / products or associated deliverables.
• Specific duties may vary depending upon prioritization of projects and programs

Experience and Qualifications :

Knowledge, Skills and Abilities :

Physical Demands :

Work Environment :

Compensation Summary :

The annual base salary for this position ranges from $174,100 to $272,100. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

Benefits Summary :

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO / AA Statement :

MSD is an Equal Opportunity / Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO / AA and Pay Transparency statement, please visit here. Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.