Process Development Scientist Job at GSK (Tuas)

Scientist, Process Development

Reporting to the Associate Principal Scientist, Process Development, the Scienti...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree with 4+ years of experience, or Master’s Degree with 2+ years of experience, within biologics process development and manufacturing under cGMP processes
Experience with cell therapy manufacturing scale-up, technology transfer, and process development methods is required
Experience with basic biological laboratory techniques such as cell culture, PCR, cell-based bioassays, and/or ELISA
Extensive experience in flow cytometry and cell-based assays is required
Strong problem-solving skills are preferred
Experience supporting regulatory documentation, including but not limited to INDs, CTAs, and BLAs
Previous experience and working knowledge of T-cells or immunological cell therapies
Good working knowledge of cGMP manufacturing for biological processes and ICH regulations
Highly organized and efficient, with a curiosity for cutting-edge science
Strong team orientation and a passion for continuous self-development

Job Responsibility

Design and execute process development experimental plans, author associated protocols and reports, and present data and insights to cross-functional teams
Develop phase-appropriate cell therapy manufacturing processes using Quality by Design (QbD) principles
Support technology transfer of processes to CDMOs for early-phase cGMP clinical manufacturing, as needed
Contribute to the development of platform manufacturing processes and ensure readiness for clinical and future commercial manufacturing
Identify and evaluate opportunities to improve manufacturing performance, including cost, throughput, robustness, and quality
Maintain laboratory materials and sample inventory to support experimental planning and execution
Accurately document experimental data in a timely manner, ensuring data integrity, traceability, and compliance with protocols
Maintain individual training requirements in a compliant state
Contribute to regulatory filings (e.g., IND/CTA) and technical documentation, as needed
Other related duties, as assigned

What we offer

health and retirement
PTO
stock option plans

Fulltime

Process Development Principal Scientist

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States of America , Cambridge

Salary:

141836.95 - 191897.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree PhD OR PharmD OR MD and 3 years of experience
Master's degree and 6 years of Scientific experience
Bachelor's degree and 8 years of Scientific experience

Job Responsibility

Lead all attribute and analytical aspects of a program in pivotal clinical process development while working cross-functionally within a Product development team
Define analytical control strategies and implement methodologies for development of late phase clinical programs including analytical method development and optimization
Lead method transfer and support cGMP manufacturing activities at internal manufacturing, and contract manufacturing and testing sites
Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities
Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification
Provide expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development
Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department
Maintain current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities and apply this knowledge to the evaluation and development of new methodologies
Recognized as a scientific resource in area of expertise who can provide mentorship to junior staff

What we offer

Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Process Development Principal Scientist

Location

United States , Thousand Oaks

Salary:

148363.00 - 171657.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

PHD degree or (foreign equivalent) in analytical chemistry, chemistry, or related field & 3 years of experience in the job offered or in a process development-related occupation. Position requires 3 years of experience in the following: 1. Mass spectrometry knowledge in mechanism of different ionization techniques, configuration of mass spectrometry platforms by different vendors including Waters, Thermo Fisher, or Agilent, and gas-phase ion chemistry for structural elucidation
2. Sample preparation including liquid-liquid extraction and solid phase microextraction for qualitative and quantitative analysis of both small molecules and large molecules
3. Analytical techniques including FT-IR (Fourier-transform infrared spectroscopy), NMR (nuclear magnetic resonance), and UV (ultraviolet–visible spectroscopy)
4. Chromatography and related separation techniques including RP-HPLC (reversed phase high-performance liquid chromatography) and GC (gas chromatography)
5. High-throughput analysis in processing multidimensional mass spectrometry-based data and implementing statistical analysis and interpreting statistical results
and 6. Software applications including ChemDraw, Xcalibur, or ChemStation and programming language for data processing including Python or Matlab.

Job Responsibility

Lead analytical method development, validation and trouble-shooting for drug substances and drug products and in-process testing for synthetic small molecules and/or synthetic peptide testing and characterization
Define analytical control strategies and implement methodologies for development of late phase clinical programs
Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives
Lead and mentor a group of analysts in supporting process development
Provide career development guidance to the team members
Provide concise summary to cross-functional leadership for endorsement of key decisions
Oversee activities at contract manufacturing and testing sites
Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents
Address analytical and product quality inquiries from health authorities
Supervises direct reports

What we offer

stock
retirement
medical
life and disability insurance
eligibility for an annual bonus
Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
discretionary annual bonus program

Fulltime

Process Development Senior Scientist

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Cambridge

Salary:

123777.00 - 167463.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree PhD OR PharmD OR MD and relevant post-doc where applicable completed by August 2026
OR Master's degree and 3 years of Scientific experience
OR Bachelor's degree and 5 years of Scientific experience

Job Responsibility

Design and develop synthetic routes and scalable chemical processes for the manufacture of synthetic and hybrid drug substances
Develop safe, robust, efficient, and cost-effective manufacturing processes suitable for clinical and commercial production
Advance enabling technologies that accelerate pharmaceutical development and improve sustainability, efficiency, and process robustness
Support cGMP manufacturing activities and assist with technology transfer efforts to internal manufacturing sites and external contract manufacturing organizations (CMOs)
Build process understanding through experimentation, process characterization, modeling, and data analysis to ensure consistent process performance
Contribute to cross-functional drug substance development teams by providing technical expertise, experimental data, scientific recommendations, and clear documentation
Collaborate across disciplines to support regulatory filings and author technical sections of regulatory documentation
Stay current with advances in synthetic organic chemistry, process chemistry, and related technologies, and apply new scientific insights to ongoing programs
Effectively collaborate within multidisciplinary teams that include chemists, engineers, analytical scientists, and other technical experts
Independently manage project activities and deliver high-quality results within established timelines

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives

Fulltime

Process Development Senior Scientist - Drug Product Technologies

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Thousand Oaks

Salary:

126066.05 - 170559.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
OR Master’s degree and 3 years of Scientific experience
OR Bachelor’s degree and 5 years of Scientific experience

Job Responsibility

Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership
Plan and execute formulation and fill/finish process studies for early-stage programs
Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on ADC drug product formulation, handling, and lab-scale sterile filling
Build process understanding across unit operations to support scalable drug product development
Evaluate in-use compatibility and drug product stability under clinical conditions
Investigate ADC- and biologics-relevant CQAs (e.g., aggregation, fragmentation, drug-to-antibody ratio, free payload, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions
Leverage high-throughput tools for formulation screening and processability assessments
Identify and address technology gaps impacting ADC stability, linker-payload integrity, protein-excipient interactions, and process-related stress responses
Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making
Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Process Development Senior Scientist - Synthetic Peptides, Oligonucleotides, ADCs

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Thousand Oaks

Salary:

126066.05 - 170559.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
OR Master’s degree and 3 years of Scientific experience
OR Bachelor’s degree and 5 years of Scientific experience

Job Responsibility

Work effectively with a diverse team of synthetic chemists, chemical engineers and analytical chemists to invent synthetic routes and develop safe, robust, sustainable and cost-effective processes for antibody drug conjugate, peptide antibody conjugates, synthetic peptides and/or oligonucleotide manufacturing
Drive technology innovation in the synthesis, purification, and characterization of bioconjugates, oligonucleotides, and/or synthetic peptides
Support cGMP manufacturing and technology transfer to our internal manufacturing facilities and external contract manufacturers
Advance enabling technologies to accelerate pharmaceutical development and to improve sustainability and process efficiency
Ensure process performance through process understanding, modeling and characterization
Contribute to drug substance development teams by providing experimental results, technical updates, documentation, data interpretation, recommendations, etc
Work cross-functionally to deliver regulatory documents and support regulatory filings
Serve as a technical expert and keep current in the field of bioconjugation, antibody drug conjugate, oligonucleotide, peptide, and process chemistry and manufacturing
Work independently in advancing projects and studies within required deadlines

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives

Fulltime

Process Development Senior Scientist

Join Amgen’s Mission of Serving Patients. In this vital role you will design and...

Location

United States , Cambridge

Salary:

139595.00 - 170664.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree or foreign equivalent in Statistics, Biostatistics or related field & completion of a university-level course, research project, internship, thesis, or one year of experience in the job offered or experience in any occupation in which the required experience was gained: Designing experiments or clinical trials to meet project requirements, regulatory standards, or scientific objectives, including development of protocols and Statistical Analysis Plans (SAPs)
Utilizing SAS, R or other statistical software to analyze clinical study data or observational study data
Assessing, implementing or developing new statistical methods to improve efficiency and validity of clinical trials
Utilizing R or other statistical software to perform simulations to evaluate operating characteristics of analytic methods or design options
Utilizing programming software to develop tools to evaluate methods or statistical designs including creation of software packages or interactive tools
Performing causal inference analyses on clinical trial or observational datasets to address potential biases and confounding factors
Employ trial design strategies to mitigate challenges such as high dropout, skewed distributions, missing data, and confounding, including the use of robust regression and imputation.

Job Responsibility

Design and analyze clinical trials, using statistical methods to support drug development and regulatory submissions
Provide statistical contributions, statistical review, and quality control of Key Design Elements, protocols, randomization specifications, Statistical Analysis Plans, Table, Listing and Graph shells, Submission Data File specifications, other key study related documentation, protocol deviations, Flash Memos, Clinical Study Reports, clinical publications, and other communications
Completing statistical analysis of individual studies/projects
Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
Being familiar with statistical policy and strategies
Stay abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field
Communicate the role of the Global Biostatistics department, and contribute to statistical training within Global Biostatistics
Assist in the review of Amgen Policies, SOPs, and other controlled documents
Assist with study and systems audits conducted by Amgen internally and external bodies
Use SAS and R to produce comprehensive tables and graphs to collect any summarize outcomes.

What we offer

Stock
Retirement
Medical
Life and disability insurance
Eligibility for an annual bonus
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Scientist II/Sr. Scientist I, Analytical Research and Development

We are seeking a Scientist II/ Senior Scientist I with hands‑on experience in ph...

Location

United States , Cambridge

Salary:

130000.00 - 180000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Degree in a relevant discipline (biochemistry, biotechnology, biological sciences, bioengineering, or related fields)
Minimum PhD with 2+ years or BS/MS with 10-15 years industry experience
Must have hands-on experience on analytical method development, optimization, qualification, and testing at GMP or non-GMP environments, supporting clinical phase programs
Experience with analysis of RNAs, proteins, protein conjugates, lipids, and lipid nanoparticles (LNPs) is highly desirable
Extensive experience with at least one or several of the analytical techniques is required: HPLC (RP, IPRP, SEC, IEX), capillary gel electrophoresis, ELISA
Experience with qPCR, DNA and RNA extraction, western blotting, UV spectrophotometry, DLS, MALS, mass spectrometry, and compendial testing will be a plus
Experience with analytical CMC development, method transfer, and QC technical support is highly desirable
A good understanding of ICH Q2 and Q14, with working knowledge on analytical Quality by Design concept
Familiarity with data analysis software such as Openlab, Chromeleon, and statistical software such as JMP
Team player with excellent oral and written communication skills

Job Responsibility

Lead early through late phase method development, optimization, and transfer for lot release, stability, and characterization of drug substances, critical materials, and drug products
Establish technical leadership as subject matter expert in multiple analytical techniques during method development and transfer and provide technical troubleshooting support when needed
Work with cross-functional groups including Research & Development, Quality Control, and Process Development teams to participate in various aspects of method development, transfer, characterization, comparability, and investigation
Coordinate routine sample testing including requests from Research and Development groups and Process Development teams
Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions
Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance
Maintaining detailed documentation of experiments in ELN system
Adapting to a fast-paced, dynamic research environment
Mentor and train junior scientists
Living Beam Therapeutics core values

Fulltime

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Process Development Scientist

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