Become A Process Development Scientist

* Scale up manufacturing processes from small scale to 50/100 kilos
* Interface with customers to spearhead technology transfer projects
* Lead a small group of 3 to 5 chemists/scientists
* Develops methods and processes that meet or exceed the expectations from clients and provide innovation as necessary.
* Researches industry practices and processes and applies to innovative development internally and for client products.
* Presents research internally and to clients.
* Leads projects with minimal supervision; may lead projects, including managing project timelines and deliverables.
* Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
* Maintains the necessary compliance status required by company and facility standards

* SCIENTIFIC/TECHNICAL
* Develop technology to deliver Amgen's API candidates in a practical, efficient and safe manner.
* Participate in drug substance teams and collaborate cross-functionally with analytical and drug product representatives to delivery drug substance manufacturing processes in a phase appropriate manner.
* Work cross-functionally to deliver CMC regulatory documents and supporting documentation in support of Amgen's small molecule regulatory filings.
* Work with external partners to deliver key intermediate or drug substances in support of Amgen's small molecule pipeline.
* Deliver processes amenable to cGMP operation and carry out deliveries of drug substance in a cGMP manufacturing environment

* Execute a wide range of experiments independently and proactively incorporate new technologies or techniques into practice.
* Initiate new research directions and novel strategies to achieve “project” or department goals.
* Effectively perform process development, process characterization, process scale-up, process technology transfer, process troubleshooting, process optimization, process robustness, continuous process improvement and process validation of MPL or QS21 or other manufacturing process.
* Develop operating process of the following unit operation as needed: extraction from biological matrices, product recovery filtration techniques; ultrafiltration and diafiltration, pasteurization techniques, lyophilization, microfluidization and other formulation techniques.
* Ability to take initiative and work proactively with creative problem solving skills, implementing strategies for completion of investigation, troubleshooting process variability, and troubleshooting remediation.
* Anticipate/ recognize potential problems with laboratory and manufacturing equipment and/or supplies and initiate action to solve or prevent problems.
* Collaborate with teams/division within the GSK organization to share relevant scientific information regarding the ongoing development projects and manufacturing processes.
* Provide technical support to GSK contract manufacturing organizations (CMO) to facilitate/troubleshoot existing manufacturing projects.
* Coordinate the efforts of technical and scientific staff to achieve project objectives and milestones.
* Implement and maintain a scientifically current, state-of-the-art laboratory environment.
* Operate a range of laboratory equipment independently.
* Comply with GMP
* GLP, cGMP, FDA/EMA regulation, quality systems, and other regulatory standards.
* Perform routine laboratory inspections to comply with Environment Health and Safety (EHS) and Process Safety Management (PSM) policies, maintain laboratory areas in a clean and safe manner and work with colleagues to create a safe environment for all to use.
* Independently writes specific technical sections of internal and external reports, publications, development reports, or regulatory documents.
* Independently prepares and communicates conclusions and recommendations for next steps, to “project” members.
* Lead and manage projects related to manufacturing process improvement within GSK using the project management methodologies.
* Environment Health & Safety:
* Performs laboratory inspections as needed for EHS reporting
* Maintains lab areas in a clean and safe manner
* Works with colleagues to create a safe environment for all to use
* Quality & Compliance:
* Complies with cGMPs, PSM and EH&S safety policies and procedures as assigned
* Continuous Improvement:
* Proactively seek assistance from other scientists to solve problems
* Anticipates/recognizes potential problems with equipment and/or supplies and initiates action to solve or prevent problems
* Proactively incorporates new technology or techniques into practice following supervisor approval and direction
* Accountability:
* Training and records upkeep
* Laboratory equipment and management systems assigned to me
* Documents written and revised with data complete and available
* Key Responsibilities:
* To support development or characterization of bulk immunostimulants (MPL or QS21) or other manufacturing processes.
* Process characterization, process scale-up, process technology transfer, process troubleshooting, process optimization, continuous process improvement, and process or equipment validation.
* Hands on experience or understanding in unit operations of extraction from biological matrices product recovery, filtration, ultrafiltration, diafiltration, lyophilization, microfluidization.
* To ensure a validated and robust process.
* To develop improvements to process efficiency and secure future production.
* To evaluate biological and process suitability of raw materials
* Why You

* Interact with investigators or clients and provide leadership and scientific expertise in the planning, implementation and manufacturing phase of major projects.
* Design and develop complex and specialized equipment and solutions.
* Work in collaboration with senior Manufacturing, Regulatory and Quality Systems staff members.
* Provide technical direction to other research staff, engineering associates, technicians, and/or students; facilitate workshops and demonstrations on research methods; educate and train users on research methodology and effective tools and techniques.
* Collaborate with other positions in facility to ensure efficient operation of facility.
* Develop and perform process development experiments on various blood, tissue and viral vector products.
* Involves independent work on isolation, culture (tissue culture vessels, bags, bioreactors), sorting, genetic modification and characterization of cells with a focus on flow cytometry and cell sorting.
* Will also develop standard operating procedures, batch records and product specifications.
* Includes assembling raw materials, following specific standard operating procedures, aseptic technique, completing batch records, reporting deviations.
* Design scale-up and scale-out process development experiments to meet clinical material requirements.
* Perform and supervises manufacturing of clinical materials (cell and viral vector products) using magnetic beads and flow cytometry technologies, bioreactors, tangential flow, chromatographic and other contemporary methods.
* Develop novel cell substrates, antibodies, molecular and cellular reagents in support of clinical manufacturing efforts.
* Present projects and data to existing and potential clients.
* Contribute to or co-author published articles, presentations, or scientific papers; identify research and development funding opportunities.
* Writes, submits and addresses reviewer comments related to novel methods in process development and manufacturing.
* Other duties may also be assigned
* Qualifications

* Serves as technical lead on internal and customer funded process development projects Participates in technology transfer programs in consultation with Process Development leadership, manufacturing personnel and EH&S representatives to allow for safe and effective implementation or modification of oligonucleotide processes.
* Review scientific journals, patents, and customer supplied technical packages and use that information to formulate a process development plan Work independently to solve non-routine biochemical synthesis problems, especially in the area of biochemistry: nucleic acid biosynthesis and handling.
* Document all work in laboratory notebook or batch records as applicable Adhere to all company environmental, health and safety policies Performs assigned group responsibilities to maintain an efficient operating laboratory May train and oversee less experienced team members in laboratory procedures, experiment design, equipment use and chemical safety/hygiene standards.
* Equal Employer