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Become A Process Development Scientist

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Working As A Process Development Scientist

  • Getting Information
  • Analyzing Data or Information
  • Identifying Objects, Actions, and Events
  • Updating and Using Relevant Knowledge
  • Documenting/Recording Information
  • Mostly Sitting

  • $85,040

    Average Salary

What Does A Process Development Scientist Do At Kelly Services

* 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

What Does A Process Development Scientist Do At Amgen

* 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

What Does A Process Development Scientist Do At Glaxosmithkline

* 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

What Does A Process Development Scientist Do At Stanford University

* 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

What Does A Process Development Scientist Do At Nitto Avecia

* 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

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How To Become A Process Development Scientist

Medical scientists typically have a Ph.D., usually in biology or a related life science. Some medical scientists get a medical degree instead of a Ph.D., but prefer doing research to practicing as a physician.

Education

Students planning careers as medical scientists typically pursue a bachelor’s degree in biology, chemistry, or a related field. Undergraduate students benefit from taking a broad range of classes, including life sciences, physical sciences, and math. Students also typically take courses that develop communication and writing skills, because they must learn to write grants effectively and publish research findings.

After students have completed their undergraduate studies, they typically enter Ph.D. programs. Dual-degree programs are available that pair a Ph.D. with a range of specialized medical degrees. A few degree programs that are commonly paired with Ph.D. studies are Medical Doctor (M.D.), Doctor of Dental Surgery (D.D.S.), Doctor of Dental Medicine (D.M.D.), and Doctor of Osteopathic Medicine (D.O.). Whereas Ph.D. studies focus on research methods, such as project design and data interpretation, students in dual-degree programs learn both the clinical skills needed to be a physician and the research skills needed to be a scientist.

Graduate programs emphasize both laboratory work and original research. These programs offer prospective medical scientists the opportunity to develop their experiments and, sometimes, to supervise undergraduates. Ph.D. programs culminate in a thesis that the candidate presents before a committee of professors. Students may specialize in a particular field, such as gerontology, neurology, or cancer.

Those who go to medical school spend most of the first 2 years in labs and classrooms, taking courses such as anatomy, biochemistry, physiology, pharmacology, psychology, microbiology, pathology, medical ethics, and medical law. They also learn how to record medical histories, examine patients, and diagnose illnesses. They may be required to participate in residency programs, meeting the same requirements that physicians and surgeons have to fulfill.

Medical scientists often continue their education with postdoctoral work. Postdoctoral work provides additional and more independent lab experience, including experience in specific processes and techniques such as gene splicing, which is transferable to other research projects.

Licenses, Certifications, and Registrations

Medical scientists primarily conduct research and typically do not need licenses or certifications. However, those who administer drugs, gene therapy, or otherwise practice medicine on patients in clinical trials or a private practice need a license to practice as a physician.

Important Qualities

Communication skills. Communication is critical, because medical scientists must be able to explain their conclusions. In addition, medical scientists write grant proposals, because grants often are required to fund their research.

Critical-thinking skills. Medical scientists must use their expertise to determine the best method for solving a specific research question.

Data-analysis skills. Medical scientists use statistical techniques, so that they can properly quantify and analyze health research questions.

Decisionmaking skills. Medical scientists must determine what research questions to ask, how best to investigate the questions, and what data will best answer the questions.

Observation skills. Medical scientists conduct experiments that require precise observation of samples and other health data. Any mistake could lead to inconclusive or misleading results.

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Process Development Scientist jobs

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Process Development Scientist Demographics

Gender

  • Male

    64.6%
  • Female

    31.6%
  • Unknown

    3.8%

Ethnicity

  • White

    65.9%
  • Asian

    22.7%
  • Hispanic or Latino

    9.4%
  • Unknown

    1.2%
  • Black or African American

    0.9%
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Languages Spoken

  • Spanish

    40.0%
  • Arabic

    20.0%
  • Carrier

    20.0%
  • French

    20.0%
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Process Development Scientist

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Process Development Scientist Education

Process Development Scientist

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Real Process Development Scientist Salaries

Job Title Company Location Start Date Salary
Staff Process Development Scientist Mallinckrodt Enterprises Webster Groves, MO Jun 30, 2016 $119,171
Senior Process Development Scientist Quanterix Corporation Lexington, MA Aug 10, 2015 $112,750
Senior Process Development Scientist Medicis Pharmaceutical Corporation Scottsdale, AZ Jan 31, 2011 $110,000
Staff Process Development Scientist Mallinckrodt Enterprises LLC Webster Groves, MO Jul 01, 2013 $109,782
Senior Process Development Scientist Quanterix Corporation Lexington, MA Nov 26, 2015 $105,000 -
$117,000
Process Development Scientist Bayer Healthcare LLC Myerstown, PA Jun 01, 2015 $100,371
Process Development Scientist Abbott Laboratories Worcester, MA Oct 13, 2010 $100,000
Process Development Scientist Asterias Biotherapeutics, Inc. Fremont, CA Apr 18, 2016 $99,015 -
$115,000
Process Development Scientist EMD Millipore Corporation Billerica, MA Aug 19, 2015 $97,000
Process Development Scientist EMD Millipore Corporation San Diego, CA Aug 10, 2015 $97,000
Process Development Scientist & Engineer GTC Biotherapeutics, Inc. Framingham, MA Jul 28, 2009 $96,923
Process Development Scientist & Engineer GTC Biotherapeutics, Inc. Framingham, MA Jul 31, 2009 $96,923
Process Development Scientist & Engineer GTC Biotherapeutics, Inc. Framingham, MA Jul 22, 2009 $96,923
Process Development Scientist Abbott Laboratories Worcester, MA Sep 10, 2011 $92,000
Process Development Scientist Abbott Laboratories Worcester, MA Feb 07, 2011 $92,000
Staff Process Development Scientist Mallinckrodt Enterprises LLC Webster Groves, MO Oct 11, 2015 $91,000 -
$137,200
Process Development Scientist Senior Lonza Biologics, Inc. Portsmouth, NH Feb 11, 2016 $90,279
Process Development Scientist Senior Lonza Biologics, Inc. Portsmouth, NH Nov 10, 2014 $88,500
Process Development Scientist III Sandoz, Inc. Wilson, NC Sep 17, 2010 $86,564
Purification Process Development Scientist Merrimack Pharmaceuticals, Inc. Cambridge, MA Nov 17, 2014 $86,111
Process Development Scientist Novartis Consumer Health, Inc. (OTC) Lincoln, NE Sep 05, 2014 $75,010
Process Development Scientist Junior Lonza Biologics, Inc. Portsmouth, NH Sep 02, 2014 $75,000
Formulation & Process Development Scientist Contract Pharmaceuticals Limited Niagara Buffalo, NY Mar 01, 2010 $75,000
Process Development Senior Scientist Keurig Green Mountain, Inc. South Burlington, VT Aug 31, 2014 $75,000
Process Development Scientist I KBI Biopharma, Inc. Durham, NC Sep 11, 2014 $74,069 -
$115,678
Process Development Scientist I KBI Biopharma, Inc. Durham, NC Sep 17, 2014 $74,069 -
$115,678
Process Development Senior Scientist Green Mountain Coffee Roasters Inc. Waterbury, VT Aug 16, 2013 $73,133 -
$85,500

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Top Skills for A Process Development Scientist

LabNotebookRecombinantProteinsValidationProtocolsAnalyticalTestMethodsProceduresChromatographyActivePharmaceuticalIngredientsProcessImprovementsFDADOEBatchRecordRevisionsHplcRProductDevelopmentGMPProcessValidationQCDataAnalysisCMOAktaPurifier

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Top Process Development Scientist Skills

  1. Lab Notebook
  2. Recombinant Proteins
  3. Validation Protocols
You can check out examples of real life uses of top skills on resumes here:
  • Reviewed department s SOPs, audited lab notebook and raw data
  • Reviewed validation protocols and protocol summaries for remediated products.
  • Audited lab and pilot processes and procedures; set policy as a site safety committee member.
  • Employed chromatography, spectroscopy and spectrophotometry techniques.
  • Manage alternate source projects for Active Pharmaceutical Ingredients (API's).

Top Process Development Scientist Employers

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