An organization is seeking a Director, Process Development – Drug Substance Technologies

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead the organization’s commercial phase drug substance team for the organization’s North Carolina Site (ANC). Responsible for scientific and technical leadership of Drug Substance (DS) manufacturing processes and technologies. Oversight responsibilities span commercialization through full scale process validation and life-cycle management of processes implemented by the organization’s North Carolina operations. You will also work in close collaboration with Manufacturing, Engineering, and Quality functions to enable progressive improvements in commercial processes. You will have direct responsibility for establishing a team of scientists/engineers to support a growing capability in a new site. Reporting to the ANC Site PD Lead, Executive Director of Drug Substance Technologies.

1. Responsible for all drug substance technology and partnership with leaders in PD for process transfer to/from the site
2. Deliver CMC authoring activities for products at the ANC site
3. Provide oversight of all process monitoring activities (real time multi-variate statistical process monitoring)
4. Drive life cycle improvements in commercial process
5. Assure manufacturing operations are aligned with the registered process
6. Provide oversight and support for technical investigations
7. Ensure safety and compliance of process development activities
8. Set goals and priorities, allocating resources, monitoring project progress, and managing the organization’s budget
9. Provide oversight and leadership of innovation and manufacturing technology advancements and implementation at the site
10. Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives.
11. Serve as member of the Drug Substance Technology (DST) extended leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities
12. Ability to travel as needed

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

1. Doctorate degree and 4 years of Process Development, Engineering or Manufacturing experience

Or

1. Master’s degree and 8 years of Process Development, Engineering or Manufacturing experience

Or

1. Bachelor’s degree and 10 years of Process Development, Engineering or Manufacturing experience
2. In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

1. PhD in Chemistry, Biochemistry, Biochemical or Chemical Engineering
2. 10+ years of experience in pharmaceutical/biopharmaceutical process development or commercial cell culture process support in a current Good Manufacturing Practices (cGMP) environment and global regulatory expectations
3. 5+ years of managerial experience in a cGMP environment.
4. Ability to identify and build a successful team that demonstrates the organization’s Values and delivers results.
5. Strong technical understanding of at least one area of drug substance bioprocessing – upstream or downstream – and able to direct aspects of area where one is not a subject matter authority
6. Ability to compile and statistically analyze data, draw appropriate conclusions and make presentations to cross-functional audience and senior management
7. Proven skills in negotiation, conflict resolution and managing customer expectations
8. Direct experience supporting commercial, biopharmaceutical process development
9. Detailed understanding of all stages of Process Validation lifecycle in biologics: Process Design, PPQ, Continuous Process Validation (CPV)
10. Demonstrated ability in providing engineering expertise to cross-functional teams Manufacturing, Quality, and Supply chain to advance complex projects to completion and to interface on technical problem resolution
11. Understanding of quality attributes of protein products and analytical methods for determination of these attributes
12. Knowledge and understanding of software tools for modeling of fluid flow, mixing, mass and energy balance, and facility utilization
13. Experience in authoring marketing authorization applications
14. Well-recognized in the scientific community through a record of peer-reviewed publications and/or patents or active in industry forums and conferences.
15. Demonstrated success developing staff, including effective feedback and coaching
16. Demonstrated collaborative experience and ability to effectively work through others
17. Strong understanding of cGMP and global regulatory expectations

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, the organization offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

1. A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
2. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
3. Stock-based long-term incentives
4. Award-winning time-off plans
5. Flexible work models, including remote and hybrid work arrangements, where possible

Salary Range
199,180.00 USD – 225,807.00 USD