This position will provide strategic and operational leadership for all CMC activities for client’s early and late stage development products. The Individual will be responsible for overseeing activities at various CMO sites to meet corporate timelines and objectives.
Areas of responsibilities include drug substance and drug product development, oversight of clinical supplies manufacturing and all other CMC activities leading to NDA filing and commercial launch. Primary responsibilities include all aspects of third-party management for Drug Substance and Drug Product supply activities as well as late stage development and process validation activities.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1) Provide leadership in development and execution of CMC activities for client’s products. Responsibilities include managing drug substance and drug product development, Phase 3 manufacturing and process validation.
2) Act as technical lead and collaborate with cross-functional teams to ensure that CMC development plans and timelines are consistent with overall regulatory and corporate strategies.
3) Oversee selection of third-party contract manufacturers and testing laboratories.
4) Provide leadership and technical oversight of external vendors conducting development, process optimization, pre-validation and validation activities.
5) Collaborate with QA and RA to ensure compliance with all relevant regulations.
6) Contribute to/author CMC sections of regulatory submissions and communications with regulatory agencies.
7) Provides strategic and hands-on management, ensuring process development, analytical development, and manufacturing activities are successful.
8) Oversees and manages Scope of Work (SoW) preparation for development and manufacturing activities.
9) Ensures that all development activities address cross-functional program team needs.
10) Develop and manage CMC program budgets.
11) Prepare reports, regulatory documents and IND sections related to CMC
Excellent planning, budgeting, and project management skills
Good influence and interpersonal skills
Strong written and verbal communication skills
Strong presentation skills
Ability to function effectively in a fast-paced, multi-tasking matrix environment
This position has no supervisory responsibilities.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk or hear. This is largely a sedentary role; however, some filing is required; it would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.
Position Type/Expected Hours of Work
This is a full-time position. The typical workweek is five eight-hour days, Monday through Friday. Occasional evening and weekend work may be required as job duties demand.
Travel is expected for this position.
Required Education and Experience
- Typically requires an M.S. or Ph.D. degree in a relevant technical field and a minimum of 10 years CMC experience in development, technology transfer and manufacturing in the pharmaceutical industry. Without an advanced degree, the additional related experience is required.
- Strong Process Development and Manufacturing background.
- Experience in aseptic manufacturing.
4. Demonstrated experience in evaluating, selecting and managing contract service providers for late-stage programs and commercial launch.
5. Experience in late-stage drug development. Track record of successful NDA or MAA programs desired.
6. Experience with pre- and post-launch activities in the biopharmaceutical industry.
7. Strong working knowledge of US and EU regulations and guidelines with a good understanding of cGMPs.
8. Demonstrated leadership in leading technical programs.
9. Strong analytical skills and the ability to understand, balance, and articulate both tactical and strategic issues and solutions.
10. Serve as the subject matter expert in drug development on CMC team.
11. Expertise in developing and managing process / analytical development, including those performed at external CMOs.
12. Experience in managing Phase III to launch manufacturing campaigns and other CMC activities.
13. Experience in preparation of CMC sections in regulatory filings.
14. Experience with oligonucleotide or peptide drug development is a plus.
Additional Eligibility Qualifications
- Computer proficiency and technical aptitude with the ability to use Microsoft products.
- Proven ability to work effectively in a team environment with associates. The capability of effective planning and priority setting. Ability to manage several complex projects simultaneously while working under pressure to meet deadlines.
- Excellent communication and organization skills.
Equal Employment Opportunity Employer
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.