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Senior Scientist Downstream Process Development Jobs in Missouri

Bioio, Inc.

Be Seen First

Senior Scientist

Saint Louis, MO · On-site

$90K - $125K/yr

Senior Scientist Bioio, Inc. | St. Louis, MO (on-site) | Full-time We're a preclinical drug ... Genuinely strong at mammalian cell culture and assay development (this is non-negotiable) * Fluent ...

Nestle

Sr Scientist

Saint Louis, MO

$97K - $133K/yr

Together, our Research & Product Development team is driven by a shared passion for pets and people ... Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you ...

KCAS Bio

Sr. Scientist - BioPharma LBA

Kansas City, MO · On-site

$89K - $122K/yr

Design and execute all phases of assigned projects including assay development, qualification ... If you would like more information about how your data is processed, please contact us.

Biomerieux

Sr. Scientist

Hazelwood, MO · On-site

$83K - $106K/yr

Performs documentation related to product development and support, including experimental planning ... Contributes to the continuous analysis process as well as to the interpretation of results together ...

BioFire Diagnostics

Sr. Scientist

Hazelwood, MO · On-site

$83K - $106K/yr

Performs documentation related to product development and support, including experimental planning ... Contributes to the continuous analysis process as well as to the interpretation of results together ...

bioMerieux

Sr. Scientist

Hazelwood, MO

$83K - $106K/yr

Performs documentation related to product development and support, including experimental planning ... Contributes to the continuous analysis process as well as to the interpretation of results together ...

bioMérieux

Sr. Scientist

Hazelwood, MO · On-site

$83K - $106K/yr

Performs documentation related to product development and support, including experimental planning ... Contributes to the continuous analysis process as well as to the interpretation of results together ...

bioMerieux Inc.

Sr. Scientist

Hazelwood, MO · On-site

$83K - $106K/yr

Performs documentation related to product development and support, including experimental planning ... Contributes to the continuous analysis process as well as to the interpretation of results together ...

Stantec

Senior Wetland Scientist

Kansas City, MO · On-site

$89K - $122K/yr

... development projects to fulfill federal, state, and local agency requirements. Your Key ... Familiarity with state and federal environmental permitting processes. * Ability to travel ...

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Senior Scientist Downstream Process Development information

What does a senior scientist in downstream process development do?

A Senior Scientist in Downstream Process Development focuses on developing, optimizing, and scaling up processes to purify biological products such as proteins or antibodies after cell culture (the 'downstream' part of biomanufacturing). They design experiments, analyze data, and work with cross-functional teams to ensure product quality and regulatory compliance. Their role is critical in moving biopharmaceutical products from research to commercial production by ensuring efficient and robust purification processes.

What are the key skills and qualifications needed to thrive as a senior scientist in downstream process development?

To thrive as a Senior Scientist in Downstream Process Development, you need advanced knowledge in bioprocess engineering, protein purification, and process scale-up, typically supported by a Ph.D. or Master’s degree in a relevant field. Expertise with chromatography systems (such as AKTA), analytical instrumentation, and familiarity with regulatory requirements like GMP are essential. Strong problem-solving abilities, leadership, and effective communication skills distinguish top performers in this role. These competencies are crucial for developing robust, scalable processes that meet quality standards and drive successful product development.

What are some common challenges faced by senior scientists in downstream process development, and how can they be addressed?

Senior Scientists in Downstream Process Development often encounter challenges such as optimizing purification processes for novel biologics, scaling up from lab to production scale, and ensuring product consistency and regulatory compliance. Addressing these challenges typically involves close collaboration with cross-functional teams, continuous process optimization, and staying current with industry advancements in chromatography and filtration technologies. Proactive problem-solving, effective communication, and leveraging data analytics are also key strategies for overcoming obstacles in this role.
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Senior Scientist Downstream Process Development jobs near you

Formulation & Process Development Senior Scientist

Virbac

Bridgeton, MO • On-site

Full-time

Retirement, PTO

Re-posted 18 days ago

Job description

Experiencing together a unique human adventure
Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.
Virbac Animal Health is seeking a Formulation & Process Senior Scientist to join our team. The Formulation & Process Development Senior Scientist develops new and optimized existing pharmaceutical products for the animal health market. Identify and evaluate new technologies and/or formulation processes Provide technical expertise in collaboration with other functional groups to prepare formulations development plans, to help establish and meet project timelines, prepare laboratory, pilot, and industrial scale batches, and support technology transfer to Industrial operations, for a variety of product dosage forms including, tablets, liquids, powders, chews and others, in compliance with cGMP, FDA and EMA regulations/guidelines. Mentor the Junior Formulation Scientists.
Experience: BS in Chemistry, Pharmaceutical Science, Chemical Process Engineer or higher degree. 5+ years of experience in a pharmaceutical-related field is desired.
Benefits: 13 Company paid Holidays; 5 personal days (prorated); 15 vacation days (prorated); 5 floating holidays (prorated); 6% 401k match; competitive pay and bonus opportunity; growth opportunities within the department and much more!
Area of responsibility 1: Development of new pharmaceutical products or optimization of existing pharmaceutical products (R&D roadmap).
Main activities
  • Lead and support the development of novel dosage forms and manufacturing processes for the delivery of drugs to animals, for internal and subcontracted projects i.e. CMOs.
  • Prepare formulation development plans to help establish and meet project timelines.
  • Lead The Quality by Design (QbD) and Design of Experiments (DOE) approach to develop products and processes that helps identify and control critical factors that affect product quality.
  • Collaborate with the global product development team to prepare, execute, and evaluate the stability of laboratory-scale, pilot and industrial scale-up batches, to test a variety of product dosage forms including tablets, liquids, powders, soft chews, sustained-release products and others.
  • Troubleshoot problem processes and suggest improvements to manufacturing Prepare and authorize manufacturing protocols, Master batch records, change control requests, deviations, development and technology transfer reports, for all scale-up or production batches.
  • Provide guidance to the product development technicians in data collection and analysis.
  • Evaluate and compile stability data.
  • Prepare product specifications and assemble documentation to support the part II of the Dossier, in collaboration with the analytical and CMC teams.
  • Work closely with manufacturing and operations teams, monitoring production runs, and ultimately, transfer of new products to industrial production. Communicate effectively in a timely manner and within a team setting, all information regarding formula and processes development, project status, results, across technical departments and the global project team i.e. Analytical, tech. Reg., QA, API, MSAT/IO etc.
  • Engage in continuous learning by attending industry expos and conferences, applying acquired knowledge.
  • Adhere to cGMP, GLP, GCP, FDA and EMA legislations and guidelines, whenever applicable.
  • Ensure answers to questions from the authorities evaluating AMM files and quality/audits inspections.

Expected results: Ensure products and accurate, robust, repeatable processes are developed in a timely manner, in agreement with the development plan, and in adherence to applicable regulation requirements.
Area of responsibility 2: Mentor the junior formulation scientists as needed, foster a culture of excellence and collaboration to maintain optimal throughput and productivity
Main activities
  • Actively demonstrate expert level knowledge and skills, in design of experiments, industrial manufacturing, packaging and technology transfer.
  • Mentor the junior scientists and expand their knowledge and technical skills. Assist the junior scientists with documentation, preparing and reviewing documentation.
  • Assist the junior scientists with implementation of new technologies and the associated instrumentation.

Expected results: Provide guidance to the juniors scientists to achieve the desired project scientific outcomes
Area of responsibility 3: Ensure (maintain/improve) laboratory compliance to GMP/GDP/GCP practices, internal SOPs and safety.
Main activities
  • Ensure data integrity and compliance to company SOPs/policies and specifications, FDA and EMA cGMP regulations, and Virbac safety policy.
  • Maintain a working knowledge of appropriate scientific instrumentation, equipment, and methodologies in manufacturing, packaging and physico-chemical characterization.
  • Adhere to overall good documentation practices (GDP). Identify and support initiation of Deviations, CAPAs and Investigations.

Expected results: Compliance of the R&D formulation lab to GMP/GDP practices, internal SOPs and safety policy.
Profile
Requirements (Diploma and experience)
  • BS Chemistry, Pharmaceutical Science, Chemical Process Engineer or higher degree
  • 5+ years of experience in the pharmaceutical-related field.

Skills
  • This individual has previously demonstrated a high level of Mastery of skills in formulation science and/or process development, project management, in a GMP/GLP environment, either within Virbac or at a previous employer.

Virbac provides numerous career opportunities, thanks to the diversity of its jobs and their international dimension.
Joining Virbac means joining dynamic teams ambitious for success.
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