Biologics Drug Product Process Development Scientist
$55 - $60 per hourAtrium
Vertex is seeking a Biologics Drug Product Process Development Scientist to join our Process Development team to support the development and manufacturing of biologics drug products for our growing pipeline. The Vertex Process Development team offers a dynamic, fast-paced, and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best process design, scale-up, and cutting‑edge manufacturing technologies to enable the successful implementation of biologics, cell, and Genetic therapeutics. The successful candidate will support the development and manufacturing of biologics drug products. The responsibilities include formulation development, primary container development, fill‑finish process development, and technology transfer of manufacturing processes to CDMOs to support our clinical pipeline. Key Duties and Responsibilities Support drug product development, process transfer, and scale‑up activities. Assess molecule developability and determine formulation screening strategies for biologics, ADCs, and other biologics modalities. Develop robust fill‑finish manufacturing processes for liquid and lyophilized drug products in vials, pre‑filled syringes, and other novel primary packaging formats. Establish preclinical and clinical dose preparation and administration protocols for drug products. Analyze and trend stability data to understand product degradation pathways and inform development strategy. Author and/or review technical protocols, reports, and documentation to support development activities and technology transfer. Perform wet‑lab activities as needed to support program objectives. Located on‑site at our Boston Seaport location. Required Education Master’s or PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or a related discipline, with 3‑5 years of industry experience, or equivalent years of education and experience; a PhD with 1‑2 years of industry experience, or equivalent years of education and experience. Direct industry experience in biologics drug product development. Required Experience and Skills Hands‑on experience in formulation development for recombinant proteins, including antibodies, ADCs, and fusion proteins. Experience developing stable, high‑concentration liquid formulations and dosage forms for biologics. Experience developing aseptic fill‑finish manufacturing processes for biologic drug products in vial, pre‑filled syringe, and cartridge formats. Experience using analytical techniques to characterize physical and chemical properties of biologics. Knowledge of cGMPs and regulatory guidelines for biologics. Familiarity with biologics upstream and downstream processes. Strong data analysis, technical writing, and scientific communication skills. 6 months with the chance to extend. Pay Range $55/hr - $60/hr Shift/Hours Monday - Friday #J-18808-Ljbffr Atrium
$90.44k - $122.36k
...the lives of patients while transforming your career.Process Development Associate Scientist- Biological and Structural CharacterizationWhat you will doLet’s... ...methods for: release testing, stability testing, product characterization/optimization, reference standard characterization...SuggestedFull timeFlexible hours- What you will do Amgen is currently seeking a talented Process Development Senior Scientist to join our Drug Substance Technologies - Synthetics (DSTS) group at Cambridge, MA. Amgen’s DSTS group within Process Development (PD) is responsible for the invention and development...SuggestedContract workRemote workFlexible hours
- Amgen is hiring a Process Development Senior Scientist to lead development, characterization, scale-up and support of drug substance processes to advance programs from Ph II/III through regulatory submission. You will work in a cross-functional team with bioprocessing,...Suggested
- Amgen in Cambridge, MA seeks a Process Development Senior Scientist to lead analytical method development for critical quality attributes in biologics. You will guide LC/MS workflows, peptide and disulfide mapping, and automated workflows to enhance efficiency and data...Suggested
- Amgen is seeking a Process Development Associate Scientist in Cambridge, MA. You will develop and transfer analytical potency and biological characterization assays, supporting sample testing and regulatory submissions. The role requires Masters or Bachelors with relevant...Suggested
$126.07k - $170.56k
...patients while transforming your career.Process Development Senior Scientist - Attribute SciencesWhat you will... ...opportunity to join the Amgen Biologics Pivotal Attribute Sciences team based... ...protein conjugates such as antibody-drug conjugates.Deep LC/MS expertise in bottom...Full timeFlexible hours$126.07k - $170.56k
...transforming your career.Process Development Senior ScientistWhat... ...-up and support of drug substance processes... ...culture and purification scientists work together to... ...pipeline. With Amgen’s biology first approach, the position... ...analytical and drug product representatives to...Full timeFlexible hours- ...Job Title: Drug Development Scientist Reports To: Director of Research / Principal Scientist... ...potential. Collaborate with chemistry, biology, and clinical teams throughout all... ..., EMA, etc.) during the development process. Maintain detailed lab records...Full time
$36 - $41 per hour
...in the world to ensure the products they supply are safe, their... ...member of the Late-Stage LNP Process Development team, the candidate will be... ...characterization of LNP clinical stage drug products. The successful... ...engineering, chemistry, or biological sciences (or related field)...Hourly payFull timeMonday to Friday- Lilly is seeking a scientist to design, execute, and oversee experiments for the development and scale-up of lipid nanoparticle (LNP) drug product processes. The role emphasizes independent leadership in LNP platform science and translation of cutting-edge formulation into...
- Join to apply for the Process Development Sr Scientist role at BioSpace . 2 days ago Be among the first... ...collaboration, to ensure success through the Drug Product commercialization process and... ...and manufacturing. Experience in biologics process development, formulation...Flexible hours
$90.44k - $122.36k
...transforming your career. Process Development Associate Scientist What you will do Let’s do... ...proteins to improve the production yields, evaluating process... ...to contribute to drug substance process development... ...unlocking the potential of biology for patients suffering from...Flexible hours$141.84k - $191.9k
...transform the lives of patients while transforming your career.Process Development Principal ScientistWhat you will doLet’s do this. Let’s... ...and hybrid molecules and collaborate closely with Drug Substance, Drug Product and Product Quality colleagueLead all attribute and...Full timeContract workImmediate startFlexible hours- ...Cambridge, MA is seeking a Scientist to work in our oligonucleotide development laboratories. The role... ...synthesis process development, characterization... ...and scale-up to support drug candidates, with opportunities... ...robustness and productivity. Required are a Bachelor...
$32 - $41 per hour
...companies in the world to ensure the products they supply are safe, their ingredients... ...Description We are seeking a process development scientist to join the messenger-RNA (mRNA)... ...experience. Experience with molecular biology and RNA biochemistry methods including...Hourly payFull timeMonday to Friday- Amgen in Cambridge, MA is seeking a Process Development Associate Scientist—Biological and Structural Characterization to develop, qualify, and transfer quantitative potency and biological assays, supporting sample testing and regulatory submissions. You will work with...
- ...company in Watertown is seeking a motivated scientist to join their team in enzyme engineering. The role involves transforming core enzymatic processes into commercial products. Responsibilities include core molecular biology techniques, designing screening experiments,...
$100k - $130k
...services that accelerate the development of groundbreaking... ...possible.The Senior Engineer, Process Validation is responsible... ...starting materials, drug substance, and drug product, product classifications... ...of process validation in biologics/small and large molecules...Full timeRemote workWork from homeFlexible hours$105.6k - $158.4k
...DescriptionGeneral Summary:The Product Development Engineering Scientist focuses on combination... ...a particular focus on drug delivery systems. The Product... ...Quality Assurance, Process Development, Clinical/Commercial... ...drug-device and/or biologic device products.Author Risk...Full timeSummer workFlexible hours- Mass General Brigham's Cancer Center Process Development Laboratory seeks a full-time Process Development Scientist I to support translational cell and gene therapy research... ...within a multidisciplinary team, bridging biology, engineering, manufacturing science, and...Full time
$145k - $190k
...is seeking a Senior or Principal Scientist to lead CHO-based cell line development for biotherapeutics. This role involves... ...and supervising development processes while managing a team of junior... ...alongside a passion for innovation in biological engineering. This position offers...- Vertex Pharmaceuticals LLC in Boston seeks a Product Development Engineering Scientist to advance combination drug-device products. You will collaborate across R&D, Quality, Regulatory, and Manufacturing to translate requirements into designs and maintain the Design History...
$36 - $42 per hour
...seeking a laboratory professional to join their Late-Stage LNP Process Development team in Boston, MA. This full-time role will involve supporting the process development and characterization of LNP drug products. Candidates must possess a B.S. degree in a relevant field...Hourly payFull time$145k - $161k
...disease with well-understood biology and a clearly defined clinical development and regulatory path, and... ...Position SummaryThe Senior Scientist / Senior Engineer, LNP Process Development will provide technical... ...(LNP) formulation and drug product manufacturing processes....Full timeContract workTemporary work- Amgen is seeking a Process Development Principal Scientist to lead analytical and regulatory efforts within the Attribute Sciences department... ...leadership across teams and collaboration with Drug Substance, Drug Product, and Product Quality to support regulatory filings...
- Pando is an AI-driven synthetic biology company revolutionizing enzyme... ...a creative and motivated scientist who thrives in the "zero-to-one" phase of product development, to assist in day-to-day lab operations... ...for taking core enzymatic processes and transforming them into...Contract work
- Vertex is seeking a Scientist to join the Process Development team in Boston, MA. The role focuses on leading development studies for a cell-based drug candidate targeting diabetes, with occasional weekend work required. The successful candidate will be a subject matter...Casual work
- Vertex Pharmaceuticals LLC in Boston seeks a Scientist to lead development studies for a cell-based drug candidate targeting diabetes. This full-time role requires... ...will mentor a team, design robust manufacturing processes, and apply DOE and statistics to optimize pathways...Full time
$60k - $96k
...General Hospital Cancer Center's Process Development Laboratory seeks a full-time Process Development Scientist I to support and advance its... ...working at the interface of biology, engineering, manufacturing... ...with viral vector production or gene delivery platforms....Full timeRemote workShift work- ...825Reference26-00568 Job Summary: Senior Product Development Engineer to support the design and development of drug-device and biologic-device combination products for a fast-growing... ...management, quality systems, and risk processes. Work cross-functionally in a fast-paced...
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