Posted to MedZilla on 4/20/2019


Takeda Pharmaceuticals

US-MA, Principal Purification Engineer, Technical Services - Manufacturing Sciences SR0034833-MZ


 
 

Primary Duties

The individual will be expected to monitor and provide support for manufacturing cell culture, recovery and Purification operations. Responsibilities will include providing technical leadership of investigations into process failures and deviations that occur during cell culture and recovery processes. The individual will also participate and function as TS lead on technology transfer teams. The individual will be responsible for oversight, coaching and mentorship of direct reports.

Responsibilities

30% Operations Support Support ongoing operations on the manufacturing floor. Respond and troubleshoot process issues; evaluate process data including bioreactor, recovery and purification performance. Provide training to manufacturing personnel. Provide inspection support as needed.

30% Tech Transfer- Provide technical leadership and ownership of key project deliverables for early to late stage clinical Tech Transfer projects.

30% Continuous Improvement - Identify, design and drive continuous improvement projects of significant impact and complexity. Provide technical oversight and leadership to junior team members; drive science based and compliant solutions.

10% Documentation Author testing/sampling protocol. Review SOP and batch record as needed.

Education and Experience Requirements

MS or PhD in Chemical/Biochemical Engineering or Bio/Chemistry with 12 + years of process development I manufacturing experience in cell culture, fermentation, recovery, separation and purification operations associated with clinical commercial biopharmaceutical GMP manufacturing.

Hands-on experience with large-scale cell culture processes, preferably with commercial or licensed products. A working familiarity with single use process systems, automation (local and distributed control systems), and sterile/aseptic processing in a cGMP environment. A detailed knowledge of the science and technology for the major unit operations associated with manufacturing operations to include cell culture, recovery, fluid transfer, filtration, chromatography, CIP/SIP, and UF/DF processes. Experience with troubleshooting / problem solving and risk assessment / mitigation. Demonstrated experience making science based and/or data-driven recommendations for manufacturing operations. Experience with process historian/data collection systems and data analysis/reporting applications such as PI Historian, MVDA (e.g. SIMCA), PI Process Book, Excel, JMP and Statistica (e.g.) is a plus.

Key Skills, Abilities, and Competencies

Hands-on experience with large-scale cell culture, recovery manufacturing and purification processes, preferably with clinical and commercial products. A working familiarity with single use process systems, bioprocess probe and sensor technology, automation (local and distributed control systems), and sterile/aseptic processing in a cGMP environment. A detailed knowledge of the science and technology for the major unit operations associated with manufacturing operations to include cell culture, filtration, CIP/SIP, UF/DF, Chromatography, Column packing and VRF processes. Experience with troubleshooting, problem solving and risk assessment I mitigation. Demonstrated experience making science based data-driven recommendations for manufacturing operations. Experience with process technology transfers. As an active participant on multiple cross-functional teams, the candidate must also demonstrate excellent written and verbal communication skills.

Complexity and Problem Solving

Candidate will make complex decisions regarding product impact on a regular basis. Candidate will also be required to assess the requirements of processes against the capabilities of existing equipment/facilities interacting with cross-functional team members for review and resolution. Candidate must be able to work in a dynamic environment, be able to set and balance priorities, and serve as a change agent.

The candidate will:

  • Develop solutions to problems of high complexity which require a high degree of ingenuity, creativity, and innovation. Contributes to the development of organizational objectives and principles.
  • Work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables. Challenges are frequently unique and solutions may serve as precedent for future decisions.
  • Creates formal network s with key decision makers at all levels within the organization.
  • Work under consultative direction toward long-range goals and objectives. Exercises latitude in determining objectives and approaches to critical assignments.
  • Decisions affect the financial, employee, or public relations posture of the organization. Erroneous decisions or recommendations would normally result in failure to achieve goals critical to the major objectives of the organization.
  • Serve as prime consultant and external spokesperson for the organization on selected matters of high significance relating to policies, programs, capabilities,and long-range goals and objectives.

Internal and External Contacts

Incumbent will work closely with Manufacturing, Quality, Engineering, Validation, Process Development, Facility and vendors.

Other Job Requirements

Limited travel may be required.

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

Reasonable Accommodations

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.


Please visit our website at takedajobs.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.