Shire Formulation/Finish Technical Services Manager in Thousand Oaks, California
This position is responsible managing the manufacturing science group within the Process Development and Technical Services function. The Manufacturing Sciences team provides technical support for commercial manufacturing operations for multiple recombinant protein therapeutics in order to meet plant goals for yields, capacity, and quality - specifically to ensure high process performance, capacity utilization and success rate. The primary focus of this potion will be specific to formulation, fill and finishing.
Specifically, the Manufacturing Sciences group is responsible for:
Leading process investigations and assess product impact for all recombinant proteins produced at the site
Identification of optimization opportunities, evaluation of local impact and implementation of process changes
Provide process expertise and equipment for process fit evaluations, technology transfers, process validation, training, regulatory support, and inspection
Primary entry point for all process-related support requests from Manufacturing and Quality
Support QbD : provide input into pFMEA, process monitoring and validation strategy
Providing technical support during regulatory inspections
The candidate will utilize a solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget. Based on significant technical expertise, the candidate will review and approve complex design concepts and provide general direction to technical staff. It is expected that the candidate will be acknowledged outside of the business unit or division for input on programs of some magnitude. The candidate is expected to exhibit creativity and innovation in completing department tasks as well as exhibit creativity and innovation in completing divisional and cross-functional/business unit responsibilities.
Essential Duties & Responsibilities
Select, develop, retain and provide general/technical leadership to a team of high professional level engineers/scientists/project managers in their assigned project activities.
Efficient & effective manufacturing support and troubleshooting for all products at the site, including support to other sites. Address in timely manner the business issues with a good balance on technical solving and transactional processes (communication, alignment).
Accountable for process yield and success rate targets.
Coordinate product impact assessments related to process deviations and non-conformities in order to support product disposition decision
Identify, evaluate and select and support the implementation of opportunities for yield improvement, or process robustness at commercial scale, together with product leads, Process Science and Project Management functions
Support technology transfer of products to or from any sites (Shire site, CMO, R&D, external partners) in alignment with the Shire Tech Transfer business process, together with the PM-TT function
Support process validation, engineering, quality and manufacturing groups by providing expertise in equipment design, process sciences, QbD, raw materials and troubleshooting analysis.
Use effective process monitoring tools (Manufacturing Data Base and Six Sigma methodology...) in order to detect potential issues that can affect quality or yield or to identify improvement opportunities
Provide input to the technology innovation strategy
Support Regulatory submissions, and Compliance inspections
Comply with c-GMPs and other regulatory, Shire requirements
May perform other duties as assigned
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Results Oriented
Be An Excellent Manager of Self and Others
Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.
Able to create and maintain an environment where team members experience personal and professional growth and become a more self-directed team
Active team orientation and collaborative skills, good communication behavior (for dealing professionally with employees, colleagues and business partners at all levels), recognition of the principles of inclusion. Ability to handle conflicts
Ability to design and implement projects/studies outside area of expertise.
Must demonstrate strategic leadership and proficient supervisory skills.
Must have passion to innovate and drive for solutions.
Must display personal accountability for results and integrity.
Must display eagerness to learn and continuously improve.
Must display strong customer focus
Must have relentless focus on rapid and disciplined action
Good technical knowledge of the formulation, fill and finishing process.
Good knowledge of process equipment and bioprocesses at commercial scale.
Proven problem solving skills and familiarity with project management and coach users on analytical tools.
Good statistical knowledge
Excellent knowledge of cGMPs, ICH guidelines
Preferred Six Sigma trained
Education and/or Experience
Bachelor’s Degree preferred in Engineering or Science is required with 8-10 years’ experience in Biotechnology/pharmaceutical organization, Master’s Degree preferred.
Normal office environment.
Pace will be fast and job completion demands may be high.
Normal office environment. May occasionally work in labs or manufacturing area with gowning required.
May travel up to 10% for business purposes
May occasionally have to work early in the morning or late at night, to accommodate interactions with partners in different time zones.
The overall physical exertion of this position is sedentary work.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.