Sr. Director, Chemistry, Manufacturing and Controls \/ Biologics

San Diego, California, United States
Nov 01, 2020
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Directs and coordinates manufacturing process development and GMP manufacturing activities for the Company's Pharmaceutical products.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
  • Plans and formulates all aspects of manufacturing process development and GMP manufacturing projects using outside vendors.
  • Provides expertise and is responsible for vendor selection, management of the manufacturing process, regulatory compliance and selection of any equipment and human resources required to complete the process within budgetary constraints.
  • Reviews, analyzes and recommends feasible vendor proposals for best outcomes with justifiable expenditures for final consideration.
  • Negotiates contracts with outside vendors (pharmaceutical manufacturers, consultants) on production of active pharmaceutical ingredients and final drug products for both development and marketed pharmaceutical products/services or research and development for the company. Works with legal to ensure the contracts are executed as per agreement.
  • Develops and implements methods and procedures for monitoring manufacturing projects such as documentation of expenditures and research findings, progress reports and staff conferences in order to inform management of current status of each project.
  • Manages CMC (chemical, manufacturing and control) aspects of projects and prepares CMC sections for regulatory submissions. Works with regulatory affairs department staff to ensure submission to regulatory authorities is of the highest quality and on schedule every time. Represents company in CMC meetings with the FDA and other regulatory agencies.
  • Establishes the audit process of vendors to ensure compliance with all regulatory agencies connected with research, development, manufacturing, packaging and distribution of both development and marketed pharmaceutical products for the company. Works with RA/QA Director to ensure company standards are adhered to and decisions regarding drug products are made in the best interest of the company.
  • Maintains up-to-date changes in regulatory policies and guidelines with regard to cGMP.

Directly supervises selected employees and consultants in the Chemistry and Manufacturing Controls team. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Position generally requires a bachelor's, masters or doctoral degree in a biology, chemistry or biochemistry with a minimum of 15 years related experience or equivalent combination of education and experience. Significant experience working in a FDA regulated pharmaceutical environment. Project management skills strongly desired.

Ability to read, analyze, and interpret complex scientific and technical journals, financial reports, and legal documents. Ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to prepare speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management and regulatory authorities.

Ability to work with mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation, sampling theory and factor analysis.

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

Certain amount of travel is expected of this job, to meet with clients, regulators, audit and conduct due diligence on API suppliers and final drug product manufacturers.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts.

The noise level in the work environment is usually quiet.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.