Director, Technical Program Design
Director, Technical Program Design
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
Position Location: US (Remote)
Key Responsibilities:
New Business Development
Support sales team with technical knowledge for viral vectors production platforms and cGMP facilities. Engage with potential clients to present companys global capabilities!
As a team we deliver technical solutions to support client product development aligning with clinical regulatory and business goals within budget and timeframe. This includes active review of client RFPs discussing technical aspects scope design for process development production and alignment with goals risk mitigation budget and timeline. One critical piece is to align allocated technical scope hours with client expectations by reviewing draft proposals and Scopes of Work. Then the team participates in client site visits and prospective project discussions.
This role stands out by representing VVS/ATx as a technical authority in industry events!
We accomplish this through promotion of VVS/ATx technical expertise and services by actively participating in industry conferences trade shows and exhibitions. We also support marketing initiatives and the publication of scientific articles and white papers to improve the visibility of VVS/ATxs expertise and services.
People Management
You will lead a team of three to six SMEs specializing in viral vector cell therapy and mRNA development for clinical and commercial programs. This role delegate tasks and offers mentorship and feedback.
Knowledge skills and abilities to be successful in this role:
- Subject Matter Expert in unit operations and processes involved in viral vector cell therapy and/or mRNA product manufacturing including drug substance and drug product.
- Advanced knowledge in manufacturing and analytical technologies brought to bear in advanced therapies.
- Knowledgeable about aseptic processing sterile fill finish techniques and container closure systems.
- Proficient in cGMP regulations BSL requirements and working collaboratively with Biosafety teams.
- Familiar with FDA and ICH regulatory CMC requirements for advanced therapies.
- Experienced in regulatory requirements for QC process release and stability testing across clinical phases.
- Outstanding interpersonal presentation and communication skills.
- Ability to manage multiple projects simultaneously.
- Willingness to travel frequently domestically or internationally.
Education
- At minimum Master of Science required in a relevant field (Biology pharmaceutical or engineering sciences) PhD preferred.
Required experience
- Ten years experience in biologics development and manufacturing industry.
- At least five years of this experience in advanced therapy products (viral vector cell therapy mRNA or combination) development manufacturing industry.
- Experience in the contract manufacturing industry preferred.
- Equivalent combinations of education training and relevant work experience may be considered.
Compensation and Benefits
The salary range estimated for this position based in North Carolina is $160000.00$213000.00.This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:
A choice of national medical and dental plans and a national vision plan including health incentive programs
Employee assistance and family support programs including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short and longterm disability in accordance with company policy
Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan
Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits please visit: Experience:
Director
Employment Type
Full-Time
Key Skills
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