Technical Services Lead - Downstream Purification - Ireland
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- Our company is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
- Our company is the global leader in complement inhibition and has developed and markets a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation.
- Our company is evaluating other potential indications for its marketed drug and is developing additional highly innovative biotechnology product candidates across multiple therapeutic areas.
- The successful applicant will be required to lead the technology transfer activities for the cGMP Biologic processes at company’s facility.
- The position will provide downstream processing expertise to support the facility design, start-up and routine commercial manufacturing.
- The Technical Services Lead will be responsible for technology transfer of new or existing drug substance manufacturing processes to the facility, and will be required to work in close collaboration with Process Development, Engineering, Validation, Supply Chain, Quality, Regulatory and other involved departments to ensure successful facility design, construction, startup and qualification.
- The position is accountable for timely completion of technical transfer related milestones, will manage technical transfer activities from planning to completion including the oversight of downstream unit operations and will address complex technical problems arising during the technical transfer.
- Responsibilities also include review and approval of CMC sections for regulatory filing documents and responses to regulatory questions.
- To provide process expertise in the area of buffer preparation and downstream processing / purification to support company’s client side design team in its efforts associated with the facility.
- To participate in cross functional downstream design teams as required in support of company’s overall design goals and expectations.
- To participate in design reviews, model reviews, etc., and to input on technical elements of the design.
- To execute P&ID, User Requirement Specification and other reviews associated with the downstream area.
- To lead process risk assessments and author and review documentation in support of equipment verification using the risk based verification approach.
- To author and review process transfer documentation, gap assessments, technical reports, process validation documents, and portions of regulatory submissions.
- To identify requirements for laboratory studies to support facility design decisions or process transfer, and to liaise closely with Process Development to oversee the design and execution of studies.
- To support the introduction of new raw materials and consumables.
- To provide technical oversight of routine process monitoring and follow-up on any significant adverse trends.
- To identify and implement process improvements; e.g. yield, cycle time reduction.
- To oversee the execution of technical studies and validation protocols on the manufacturing floor. Temporary shift working may be required during periods of engineering batch and validation batch execution.
- To lead manufacturing floor support for troubleshooting and investigations into downstream processes and provide general technical oversight of process.
- To author and review IND, BLA and other technical documents for regulatory agency submissions.
- To serve as a subject-matter expert on technology transfer and process support during regulatory agency inspections.
- 5-8 years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
- In-depth technical and operational knowledge of multiple unit operations in downstream processing, including buffer preparation, chromatography, ultrafiltration / diafiltration and membrane filtration.
- Strong understanding of technology transfer, scale-up, process and cleaning validation.
- Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
- Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization.
- Ability to present and defend technical and scientific approaches in both written and verbal form.
- Experience of authoring CMC sections of regulatory submissions would be an advantage.
- Ability to influence others without direct authority and communicate with all levels of the organization
- Ability to drive for results independently and adapt to rapidly changing priorities
- Experience of Validation / Verification of GMP equipment or processes would be beneficial.
- Experience of design, commissioning and start-up of a bulk drug substance facility would be beneficial.
- Drive for Results
- Decision Quality
- Problem Solving
- Motivating Others
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas