Senior Downstream Development Engineer II
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The Sr. Development Engineer will be a key contributor within a group responsible for performing purification process development, including small-scale experiments, scale-up, technology transfer and support for programs that bring new bio-pharmaceutical products to pre-clinical, clinical and commercial manufacturing phases.
- Will be a leading contributor during execution of purification activities for the department, including troubleshooting problems, analyzing data and authoring technical reports and memos.
- Will lead internally developed programs
- Will effectively manage external programs through contract-based organizations (CMOs, CROs and CDMOs)
- Will design and carry out experiments for purification process development, optimization and characterization studies for therapeutic proteins. The scope includes IND- and BLA-enabling studies and preparation of regulatory submissions.
- The experimental studies involve both lab scale and pilot plant runs, including, but not limited to toxicology, clinical and validation batches.
- Will seamlessly collaborate and communicate within the framework of cross-functional, multi-disciplinary process development teams.
- Will interact extensively with other departments such as research, internal manufacturing, external contract manufacturing, facilities/engineering, supply chain, project management, procurement and quality.
- Will work autonomously to discover solutions for problems of broad scope and complexity under general guidance.
Other responsibilities: 35%
- Laboratory experimentation, project leadership, manufacturing support and CMO/CDMO management related work to support process development, optimization and characterization.
- Participates during technology transfer of programs spanning all phases of biopharmaceutical lifecycle, including discussions of scale, equipment design and manufacturing. Interacts with manufacturing operations staff, troubleshoots problems and supports their operations.
- Writing and reviewing of data summaries, technical reports, tech transfer packages, regulatory submissions and presentations.
- Organizational support and cross-functional project team participation. Advises management on goals and project direction.
- Provides guidance on design of experiments, data analysis and derivation of appropriate conclusions to junior staff.
Education and Experience Requirements:
- PhD with (5+ years), or MS with (8+ years) or BS (10+ years) in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, Biology or related discipline with relevant product and process development experience in the biotechnology/pharmaceutical industry.
- Technical expert in the field of separations, including small-scale process development and optimization, scale-up, tech transfer and manufacturing support to large scale operations.
- Advanced understanding of scientific theories, concepts, experimental techniques and industry practices and standards.
- Keeps current with latest literature and technologies.
- Proven record of technical leadership, including the ability to motivate and influence technical rigor.
- Uses project leadership skills to drive the planning and management of risks, priorities and contingencies.
Key Skills, Abilities, and Competencies:
This person must have extensive knowledge and experience on phase-appropriate purification process development and associated unit operations, including:
- Product harvesting (clarification and capture) from production bioreactors
- Purification from both microbial and mammalian sources
- Purification of different biologic modalities: Non-Fc recombinants, MAbs, and Fc-fusion proteins
- Chromatography (IEX, Affinity, HIC, Mixed-mode)
- Filtration (depth filtration, viral filtration, sterilizing filtration, ultrafiltration/diafiltration)
- Familiarity with cell culture processes and analytical characterization of proteins is preferred.
- Must have solid experience in design of experiments, process monitoring, process risk assessment, statistical analysis and the ability of interpreting data and deriving conclusions.
- Must demonstrate excellent written and verbal communication skills.
- Contributes to the preparation of CMC sections of regulatory filings.
- Authors and reviews high quality technical reports and presentations for management and peers. Independently refers to procedures, policies and practices for guidance.
- Contributes to publications in the field of expertise.
- Knowledge of cGMP manufacturing is required.
Complexity and Problem Solving:
- The candidate will lead small scale development, scale-up and technology transfer of purification processes.
- Will be expected to design, carry out and lead experimental and theoretical studies under general oversight.
- Will be expected to display sense of urgency while completing critical tasks and effectively manage his/her time.
- Will also be expected to provide original solutions to complex problems while attaining a good balance between theoretical, experimental and practical approaches.
- Provides expert input for project design and development.
- Makes sound and timely decisions based on functional priorities.
Internal and External Contacts
Individual will work closely with all internal stakeholders within purification as well as other process development groups such as cell culture, analytical, formulation, pilot plant, etc.
There is also the need for company-wide, cross-functional interactions with key partners and customers that include other departments such as research, internal manufacturing, facilities/engineering, supply chain, project management, procurement and quality. Individual will also work with external vendors, including contract manufacturing organizations.
- Effective communication, interpersonal and organizational skills are required.
- Successfully conveys very complex information from multiple sources in both written and oral forms.
- Proposes technical strategies and frequently discusses soundness of technical judgment and progress to meet objectives and timelines with supervisor and peers.
- Presents to department, project team meetings, management and external conferences / symposiums.
- Acts as departmental or inter-departmental project team lead.
- Fosters interactions, communicates and influences decisions across multifunctional areas and platforms.
- Acts as team member or lead contact on external collaborations and with contract laboratories.
- Networks externally with industry peers.
Other Job Requirements
This position will be within Takeda’s Massachusetts operations (Lexington). The candidate may be asked to travel occasionally (domestically and internationally) for conferences, seminars, and project specific needs.
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.
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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 SR0045349
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