Director, Technical Operations

---

Job description

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit

Position Summary:

The Director, Technical Operations (MSAT) provides direction, leadership, vision, and technical guidance to a team of (senior) engineers and specialists and has overall responsibility for the following areas: New Product/Process Design & Tech Transfers, Pharmaceutical Validation Program, Product/Process related performance and improvements, implementation of New Process-related equipment and components, supporting capital projects, and implementation of new capabilities.

As a member of the Site Leadership Team, the individual contributes to the result of the facility through the definition of goals, compliance with budgetary objectives, employee management, and participation in site safety programs.

Position Responsibilities:

• Direct and control the activities for biopharmaceutical process transfer and validation.

• Initiate and oversee multiple simultaneous projects that are complex and technically demanding, mainly focused on drug substance and product filling.

• Participates in Client meetings for technical discussions related to all facets of product transfer and manufacturing.

• Manage the process and resolution of technically-related deviations (through root cause investigations), understand process trends, and/or improve process performance.

• Responsible for balancing day-to-day technical support for manufacturing and longer-term projects, investigations, and project team responsibilities

• Conduct briefings and technical meetings for top management and customer representatives.

• Ensure all direct reports, including personnel, contractors, consultants, and temporary employees who work in the department and directly or indirectly support a cGMP activity, have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations.

• Ensure individual training/learning and development plans are kept current and that employees complete, and document all required initial and continuing learning.

Minimum Qualifications:

• In-depth knowledge of Drug Substance and Drug Product manufacturing processes, including formulation, process development, scales-up, and technology transfer.

• Knowledge of regulatory requirements governing biopharmaceutical manufacturing, including cGMP, EMA, and ICH guidelines.

• Direct experience in sterile and/or aseptic manufacturing operations

• Experience with process validation, process characterization, and risk assessment methodologies.

• Proven expertise in successfully delivering business-critical projects involving cross-functional participants, stakeholders, and organizations.

• Demonstrated sound judgment, good business acumen and strong analytical skills.

• Demonstrated ability to lead and mentor a team of technical professionals, including scientists, engineers, and technicians.

• Strong and highly effective strategic thinker and problem solver with high degree of emotional intelligence, with the ability to both recognize and anticipate problems.

• Proven track record of driving innovation, continuous improvement, and operational excellence initiatives within manufacturing operations.

• Demonstrated ability to translate solutions into viable action plans at a network level that are effectively disseminated and implemented through cooperation of stakeholders.

• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

• Self-motivated, comfortable with ambiguity, and innovative when developing solutions.

Preferred Qualifications:

• Advanced degree such as Master's or Ph.D. in Chemical Engineering, Biochemistry, or a related field.

• Substantial experience in biotechnology manufacturing, process development, or MS&T.

• Project management leadership or strategic planning development and assessment experience.

• Possess knowledge and understanding of product life cycle management.

• Experience with commercialization and launch of new products.

Role/Site Specific Requirements:

• This role is primarily a Sedentary role. This can include exerting up to 10 pounds of force to move objects.

• Visual acuity such as: working with data & figures, viewing computer terminal, and extensive reading.

All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $150,000.00 - $217,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

<!– job description page –>