Associate Director/Director - Biologics Downstream Process Development

Compensation

: $101,370.00 - $167,060.00 /year *

Employment Type

: Full-Time

Industry

: Executive Management



Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases and oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, multiple sclerosis and oncology. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts and research and manufacturing facilities in Athlone, Ireland and Wilmington, Ohio. For more information, please visit Alkermes' website at ****Director - Biologics Downstream Process Development

Associate Director/Director Biologics Downstream Process Development
Location
Waltham, MA, United States
Posted on
Jul 30,2019
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Position: Associate Director/Director - Biologics Downstream Process Development
Company Overview
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases and oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, multiple sclerosis and oncology. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts and research and manufacturing facilities in Athlone, Ireland and Wilmington, Ohio. For more information, please visit Alkermes' website at ****Director - Biologics Downstream Process Development
This position is responsible for leading the Biologics Downstream Process Development Team in taking Alkermes' biologics candidates from discovery through process development, scale-up, optimization, process characterization, tech transfer, clinical production, validation and commercial launch. The Team will also work with external development and manufacturing organizations. The Biologics Process Development labs will be located in Waltham, MA with scale-up capabilities up to 200 L scale.
This position will lead a group responsible for:
Downstream process development, scale up, and optimization
Process Characterization and Control Strategy Development
Tech transfer to CMO/CDMOs
Support validation and commercial launch
Technical support to CMOs for deviations and investigations
Qualification of new vendors and CMO/CDMOs
Authoring and reviewing technical reports and relevant regulatory submissions
Supporting the Regulatory group in responding to agency questions
In-depth knowledge in GMP systems, sterile processing, and US/EU requirements
Manufacturing tox and clinical supplies
Working closely with Biologics Discovery, CMC teams, and Technical Operations to ensure product success
Education / Experience
Qualified candidates should have a PhD in Engineering with 15 years technical and management experience in biopharmaceutical based process development and GMP manufacturing with an established track record of successfully developing and commercializing biologic products and processes.
Skills / Attributes Needed
Leadership & Management
Strong leadership qualities (integrity, honesty, empathy, confidence, inspiration, commitment, passion, good communicator, decisive, accountable, delegates, empowers, creative/innovative)
A collaborative, passionate, empathic personality with excellent interpersonal skills that positively influences the group culture and team dynamics
Active participation in team environments and freely offers constructive opinions and suggestions with the expectation they will support their teammates to assure project success
Ability to lead and influence technical teams and mentor less experienced scientists and engineers
Foster a culture of continuous improvement and operation excellence
Detailed understanding of science and engineering principles along with up to date knowledge ofupstream biologics processing technology and regulatory expectations
Experience with developing process for novel modalities and non-antibody recombinant protein products expressed in mammalian cell culture
Experience in downstream biologics process development, scale-up and optimization along with a strong understanding of analytical technologies that can help enhance process understanding
Demonstrated expertise and understanding of downstream unit operations such as chromatography, UF/DF, Depth Filtration, Centrifugation, Nanofiltration and viral clearance steps
Experience with pilot scale operations and large scale equipment
Energized solving technical problems, learning, creative thinking, and critical analysis and is committed to taking action and getting results
Demonstrated knowledge and experience in designing experiments (DOE) and establishing operating ranges as well as establishing control strategies
Excellent verbal, writing, and presentation skills with the ability to present concepts and results in a convincing, confident manor and to adjust presentation depth to meet needs of the intended audience
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Experience Level:
Mid-Senior Level
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Qualified candidates should have a PhD in Engineering with 15 years technical and management experience in biopharmaceutical based process development and GMP manufacturing with an established track record of successfully developing and commercializing biologic products and processes. Skills / Attributes Needed Leadership & Management Strong leadership qualities (integrity, honesty, empathy, confidence, inspiration, commitment, passion, good communicator, decisive, accountable, delegates, empowers, creative/innovative) A collaborative, passionate, empathic personality with excellent interpersonal skills that positively influences the group culture and team dynamics Active participation in team environments and freely offers constructive opinions and suggestions with the expectation they will support their teammates to assure project success Ability to lead and influence technical teams and mentor less experienced scientists and engineers Foster a culture of continuous improvement and operation excellence Detailed understanding of science and engineering principles along with up to date knowledge ofupstream biologics processing technology and regulatory expectations Experience with developing process for novel modalities and non-antibody recombinant protein products expressed in mammalian cell culture Experience in downstream biologics process development, scale-up and optimization along with a strong understanding of analytical technologies that can help enhance process understanding Demonstrated expertise and understanding of downstream unit operations such as chromatography, UF/DF, Depth Filtration, Centrifugation, Nanofiltration and viral clearance steps Experience with pilot scale operations and large scale equipment Energized solving technical problems, learning, creative thinking, and critical analysis and is committed to taking action and getting results Demonstrated knowledge and experience in designing experiments (DOE) and establishing operating ranges as well as establishing control strategies Excellent verbal, writing, and presentation skills with the ability to present concepts and results in a convincing, confident manor and to adjust presentation depth to meet needs of the intended audience


Associated topics: biological engineer, biomaterials, enzyme, fermentation, genetic, molecular, neuroscience, nutrition, parenteral, pharmaceutical * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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