Associate Director, Manufacturing Sciences

The Associate Director, Manufacturing Sciences will lead a diverse team within Operations where they will be responsible for technical transfer of new products, manufacturing, quality control, post-launch product support, complex issue resolution, process and product improvement/enhancement, and risk mitigation activities within a GMP environment. This role will be responsible for design, execution, and maintenance of validated systems and will lead and support cross-functional teams to meet business objectives.

• Lead a Manufacturing Sciences team to drive initiatives that align with business needs; including, but not limited to, Technical Transfer, Validation, Manufacturing, and Quality Control.
• Manage the core production business; including, but not limited to, Quality Control testing, ensuring product availability and quality, and working with other Production leadership and cross-functionally to meet build plan requirements.
• Serve as Operations core team member for new product pipeline projects collaborating with R&D in developing, transferring, scaling, and validating manufacturing processes and quality control test methods for commercial release.
• Oversee activities related to developing, qualifying, and troubleshooting analytical and functional test methods, manufacturing processes, and materials associated with oligonucleotides, enzymes, antibodies, and molecular biology reagents used in complex molecular diagnostics products.
• Lead and support troubleshooting of Out Of Specifications (OOS), non-conformances (NCMRs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
• Oversee Validation Program and maintain the qualified state of validated systems (Equipment, Facility, Computerized Systems, Processes, Test Methods, etc); provide technical leadership and assistance to Supply Chain partners in Supplier Change Requests (SCR), raw material feasibility, alternative supply evaluation, and risk mitigation activities.
• Partner with Supply Chain in interactions with vendors on a technical level to resolve challenges with raw materials or processes established and/or develop new processes to implement with our strategic partners to improve reliability of incoming materials.
• Generate clear and accurate experimental protocols, draft procedures, characterize and develop test methods, and test method improvements summarizing activities through technical or investigative reports.
• Develop and oversee soft-skill training curriculum within the functional team to drive team member engagement and development.
• Provide visibility and supporting information to assist leadership in prioritization of projects based on changing functional needs, resource capacity constraints, risk exposure, and ensuring clarity in project interdependencies.
• Manage and ensure cost of goods (COGs) is in alignment with the business needs and capture all costs appropriately into the enterprise-wide system; including, but not limited to, bill of materials (BOMs) and routings working closely with Finance and Supply Chain.
• Oversee design and execution of complex studies and designed experiments using appropriate statistical techniques.
• Oversee design and execution of stability studies according to recognized standards.
• Provide thought leadership in design for manufacturability for future products and test methods in collaboration with R&D.
• Oversee teams conducting bench level experiments within several product or technology areas to identify problems and discrepancies.
• Lead and manage several varied projects at one time, with frequent changing priorities.
• Supervise staff including but not limited to organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
• Communicate goals clearly to employees to ensure understanding and success in achieving them.
• Motivate and inspire employees to do their best work through coaching.
• Maintain morale and support employee engagement initiatives.
• Communicate to all levels within the company and thrives in a fast-paced, everchanging environment.
• Strong analytical, problem-solving, and negotiating skills; ability to make decisions with limited information and operate with autonomy.
• Strong documentation, attention-to-detail, and procedure writing skills suitable for a GMP environment.
• Ability to interpret technical data and present findings to management.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to work designated schedule.
• Ability to lift up to 50 pounds for approximately 5% of a typical working day.
• Ability to utilize lab equipment for 10% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability and means to travel between Redwood City locations.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

• Bachelor's degree in Chemistry, Molecular Biology, or a science related field; or an Associates degree and 2 years of relevant experience in Chemistry, Molecular Biology, or a science related field in lieu of Bachelor’s degree.
• 12+ years of industry experience with biochemical and molecular based products.
• 7+ years of direct leadership experience.
• Proficient in Microsoft Office.
• Professional working knowledge with 21 CFR Part 820, ISO 13485, and/or cGMP structured environments.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

• 10+ years of experience with Medical Device Products in a Product Development, Product Support, or Quality Control role.
• 7+ years of experience with Project Management principles and practice.
• 2+ years of experience working within Enterprise Resource Planning (ERP) systems such as SAP.
• Professional working knowledge in statistical and mathematical methods in biology/genetics, including experience with JMP software.
• Professional working knowledge in Design for Six Sigma and Statistics.
• Professional working knowledge in basic and advanced continuous improvement methodologies/principles such as LEAN Six Sigma and/or Practical Process Improvements (PPI).

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.