The Process Development Manager will be responsible for leading a small team in designing and executing bench-scale experiments to characterize and optimize manufacturing processes involving production of biologics (plasmid DNA, protein, and/or RNA). The Process Development Manager will work with research scientists, engineers, operators, and their associated groups to implement and validate new processes and to troubleshoot any process-related issues. He or she will lead a team in developing and scaling processes for clinical stage products and is expected to provide technical support for manufacturing operations and business development as needed.

This position is a leadership role and responsible for developing and coaching direct team members, employee development and fostering a culture of team work, collaboration, and ability to advance group goals to meet company objectives.

Wacker is a safety-first culture, the Process Development Manager will be responsible in maintaining a safe work environment, following all safety rules and wearing appropriate PPE when needed. Identifying any potential safety issues and reporting such issues and assist in rectifying, if applicable.

Essential functions of this position:

• Manage the day-to-day operations of the Process Development Team, as well as hiring, performance reviews, and training needs. Lead and develop team members. Implement training and maximize employee performance and engagement.
• Develop technical capabilities and scientific competencies within the PD group to match customer requirements and business needs.
• Guide studies, execute experiments, analyze data, and create study reports to document results.
• Interact with Manufacturing, Engineering, QA, QC, Legal, and other departments as needed to accomplish company objectives.
• Ensure a safe and secure work environment for team members. This includes developing and implementing safety procedures for the Process Development lab as necessary, conduct regular inspections and audits, investigating safety incidents and making recommendations for safety improvements.
• Provide technical assistance to other departments to resolve process-related issues under tight deadlines.
• Present study plans and results to project teams, colleagues, and customers.
• Ensure the scale-up and transferability of manufacturing processes for customer projects.

Position Qualifications:

• Bachelor of Science degree in Biochemistry, Biological Sciences, Bioengineering, Chemistry, or related scientific discipline.
• Minimum 8+ years of experience with a bachelor's degree, or 5+ years of experience with a Master's degree in Chemical or Biochemical Engineering or related discipline in a process R&D function.
• 2+ years of people management experience
• Travel as necessary, minimum 5%
• Strong background in biologics (nucleic acid and/or protein) manufacturing and technology transfer
• Ability to anticipate and identify problems, consider alternate approaches, and recommend effective and practical solutions based on sound engineering and scientific judgment
• Experience using Design of Experiments (DOE) techniques to quantify process responses to multifactor inputs
• Leadership experience with strong interpersonal and communication skills, both verbal and written, and the ability to work effectively in a team-oriented environment.
• Ability to plan ahead, organize and prioritize workload, coordinate activities with other groups, and meet project deadlines.
• Experience with process validation / process characterization and related concepts is highly desirable
• Experience with mRNA and/or protein production is a plus

The anticipated salary range for candidates who will work in San Diego is $120,000.00-150,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc . Wacker is a multi state employer and this salary range may not reflect positions that work in other states.

• Compensation and Incentive plans
• Medical, Dental, and Vision Insurance effective day 1
• Paid Time Off in addition to personal days and holidays
• Paid parental leave
• Wellbeing fund
• Flexible hybrid work arrangements
• 401(k) with company match
• Education Assistance Program
• Career development and advancement opportunities
• Support for Community Involvement