Associate Director, Upstream Operations
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Associate Director, Upstream OperationsApply Now
The Associate Director, Upstream Operations will provide management oversight and administration of the Manufacturing Upstream Operations. These operations include Media Solutions, Weigh and Dispense, Inoculum, Bioreactor and Recovery Operations. The Associate Director is accountable for managing the activities of the staff, monitoring the maintenance of equipment and facilities in production, overseeing complete documentation of all required production activities and ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices.
- Accountable for all Upstream Operations, including business processes and oversight of governance processes such as daily visual management meetings
- Be an active member of the leadership team to drive health of value stream
- Oversee the manufacturing area schedule to ensure supply targets are met
- Monitor expenses and maintain departmental budget
- Provide technical expertise to drive resolution of manufacturing exceptions
- Accountable for value stream to deliver continuous improvement efforts to translate the business
- Provide support for project portfolio management (capital projects and technology transfers)
- Support interdepartmental collaboration to provide continuity between manufacturing plants
- Responsible and accountable for delivery of functional area objectives on time and within budget
- Partner with cross-functional colleagues to drive solutions to issues and partner with Tech Transfer teams to support launch of new products
- Conduct routine staff meetings to ensure communication and engagement
- Ensure staff development plans are in place and routine development discussions are held
- Establish department goals in accordance with site objectives
- Maintain and promote a safe working environment
- Manage safety risk through Safety Trainings, and elimination of risks for critical operations. Support and champion safety initiatives
- Manage headcount and partner with recruiting to staff positions
- Ensure adequate training of departmental personnel in cGMPs and SOPs
- Drive a speak up culture for both safety and quality, and engage team in driving system improvement
- Participate in facility and process inspections by domestic and international regulatory agencies
- Accountable for driving safety investigations to closure with focus on preventing re-occurrence
- Ensure that all SOPs and batch records are maintained to reflect current manufacturing methods and are in conformance with product licenses
- Assure that production equipment and facilities are maintained in proper working condition and in a validated mode by assuring use of Change Control procedures
- Ensure timely submission and completion of all area quality documentation to meet established timelines
- Ensure that all compliance commitments are completed on time and provide documented evidence to support closure of each item according to the established timeline
Education and Experience Requirements
- Bachelor’s degree in Biology, Chemistry, or related field with 6 years of relevant experience
- Master’s degree in Biology, Chemistry, or related field with 4 years of relevant experience
- 10+ years of industry experience
- 3+ years of biologics, manufacturing, and management experience
- 3+ years’ experience as an area Manager /Associate Director in a bioprocessing manufacturing environment
- Knowledge of cGMPs, other regulatory requirements, and aseptic processing is required
- Knowledge of bioreactor single use systems, chromatography, and tangential flow filtration
Key Skills, Abilities, and Competencies
- Must be able to inspire and motivate a Manufacturing team through leadership and implementation of effective management tools
- Manage through adversity
- Must have lean experience to drive business improvements
- Must understand the needs of key collaborators and customers and interact effectively intra- and inter-departmentally to achieve alignment
- Must be self-motivated and driven to independently accomplish department goals and objectives
- Must possess excellent team management and presentation skills
- Must possess Judgement and Decision-Making, Inspiring and Motivating Others, Developing Organizational Capability, and Accountability & Ownership
- Strong communication and interpersonal skills are essential
- Must possess knowledge of project management and experience of collaborating cross-functionally teams
Complexity and Problem Solving
- Incumbent is responsible for resolving Issues and making recommendations to meet plant production plan in a compliant manner
- Decisions made to support the manufacture of high-quality biopharmaceuticals to our patients
- Solicits input from other function areas as required to facilitate timely decisions
- Directly involved in policy setting and execution to improve plant operations
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, 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.
Job ID SR0056817