Director, Technical Program Design - Thermo Fisher Scientific : Job Details

Work Schedule

Environmental Conditions

Job 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 company's 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/ATx's 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

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 long-term 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

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