https://JOBS.THESTEELYGROUP.COM/ en-us
Responsibilities:

• Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development in support of commercialization and life cycle management of biologics.
• Support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).
• Evaluate process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization, particle quantitation/characterization, physical properties, etc.
• Data analysis and documentation/review in electronic notebooks.
• Author, review, and data verify technical documents such as protocols, reports, regulatory documents, etc.
• Clearly and consistently communicate data in progress reports and presentations.
• Participate in cross-functional teams in a fast-paced environment to progress product development.
• Adhere to all training, compliance, and safety guidance.
• Support lab operations and inspections as required of all lab-based staff.
• Work primarily onsite with remote work as appropriate to role and tasks.
• Support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).
• Evaluate process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization, particle quantitation/characterization, physical properties, etc.
• Data analysis and documentation/review in electronic notebooks.

Basic Qualifications:

• Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience

Preferred Qualifications:

• Bachelor’s Degree in Engineering, Chemistry, Biochemistry, Pharmaceutics, Materials Science, or related discipline with at least 2+ years of relevant laboratory work experience. Or Masters degree without any experience.
• Understanding of physical/chemical stability of proteins.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with procedures and policies.
• Proficient computer skills, including Microsoft Office, PowerPoint, Word, and Excel.
• Self-motivation, adaptability and a positive attitude.
• Critical thinking, problem solving, and independent research skills.
• Good organizational skills with strong attention to detail.
• Excellent oral and written communication skills.

]]> Sat, 18 Apr 2026 00:00:00 EDT 0 Seeking a highly motivated scientist. The ideal candidate will have a PhD and approximately 3–5 years of relevant experience, with a strong background in molecular biology and a balanced skill set spanning both wet-lab experimentation and data analysis. Experience with Bioinformatics and laboratory automation and robotics is essential. Familiarity with Hamilton scripting is highly desirable, and Python scripting is preferred but not required. Exposure to machine learning is a plus.

Key Responsibilities:

• Plan, conduct, monitor, analyze, and document experiments with limited supervision.
• Follow established experimental designs and protocols to generate robust, reproducible, and reliable data.
• Adapt methods from the scientific literature for lab implementation and modify them as needed.
• Develop and implement new protocols with moderate review for automation integration.
• Interpret data (NGS sequencing data) and communicate findings clearly to the work group.
• Participate in scientific discussions and contribute to problem-solving efforts.
• Develop systems and practices to ensure high-quality data generation and organization.
• Operate, troubleshoot, and optimize standard laboratory equipment and major instruments/techniques.
• Resolve experimental and equipment-related issues effectively.
• Contribute to reports, presentations, publications, regulatory documents, invention disclosures, and/or patent submissions, as needed.
• Exercise sound judgment in determining when to work independently and when to seek input.

Basic Qualifications:

• PhD in Molecular Biology, Cell Biology, Bioengineering, Biotechnology, or a related scientific field.
• Approximately 3–5 years of relevant experience in industry, academia, or postdoctoral research.
• Strong background in molecular biology.
• Experience independently conducting and troubleshooting laboratory experiments.
• Ability to analyze, interpret, and communicate experimental data effectively.

Preferred Qualifications:

• Balanced experience in both wet-lab work and data analysis.
• Hands-on experience with laboratory automation and robotic platforms.
• Experience with Hamilton liquid handler scripting is highly desirable.
• Python scripting experience is desirable, but not required.
• Familiarity with automation workflows in a research or development environment is strongly preferred.
• Exposure to machine learning is a plus.

]]> Sat, 18 Apr 2026 00:00:00 EDT 0
Responsibilities:

Support oversight of suppliers through:

• Reviewing recently qualified suppliers for accuracy and consistency across RDSG tools/systems
• Facilitation of supplier governance meetings, as needed
• Support Governance Leads with scheduling meetings and taking minutes, as needed
• Support identification and implementation of best practices from company functions and therapeutics areas
• Contribute to departmental and cross functional initiatives and special projects as identified by management or business needs
• Manage and maintenance of RDSG tools including but not limited to Smart Sheets, Teams sites, SharePoints, and Power Apps
• Fulfilling Onboarding / offboarding requests of FSP users as part of the Business Support team.

Requirements / Qualifications:

• Master’s degree OR Bachelor’s degree and 2 years of Supplier Governance experience OR Associate’s degree and 6 years of Supplier Governance experience OR High school diploma / GED and 8 years of Supplier Governance experience
• Excellent verbal and written communication skills.
• Strong IT skills for tools/systems maintenance
• Communicates effectively within department and problem solving mindset
• High attention to detail/reporting accuracy, while also able to focus on the overall problem/solution
• Completes projects and makes decisions with minimal direction and strong ability to develop prioritization and completion timeframes for multiple assignments
• Tolerance of ambiguous situations
• Strong project management skills and leads projects as required
• Provides analyses and recommendations to support decisions by team management

]]> Thu, 16 Apr 2026 00:00:00 EDT 0
Responsibilities:

• Develop and optimize bioassays to ensure successful implementation and routine execution, supporting high-throughput screening (HTS), hit characterization & assessment, lead optimization, and mechanism-of-action (MOA) studies.
• Design and conduct laboratory experiments, generate and interpret data to facilitate the development of assays and evaluate therapeutic agents.
• Learn, apply, and integrate automation solutions during assay development, MOA studies, data analysis, and reporting processes.
• Design, optimize, and implement workflows for cell line generation to enable the development of cell-based assay for screening and/or lead optimization.
• Plan and execute experiments semi-independently and adapt readily to evolving project needs.
• Identify, evaluate, and implement novel methods and techniques to develop robust bioassays, generating reliable and reproducible data efficiently.
• Stay current with the latest scientific literature and actively contribute to the interpretation of results.

Basic Qualifications    

• Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience

Preferred Qualifications

• Experience in collaborative work within a multi-disciplinary team in a biopharmaceutical environment.
• Strong scientific foundation in understanding and implementing various bioassays and readouts, including TR-FRET, BRET, Alpha, MSD, HCS, luminescence, and fluorescence.
• Expertise in the development and implementation of target engagement (TE), activity, functional, and phenotypic, and protein-protein interaction (PPI) assays to assess therapeutic agents, including thermal shift assay (TSA), probe displacement, second messenger, ion flux, reporter, protein stability, PPI (NanoBiT, NanoBRET, etc.), immunoassays, gene activation, and cellular imaging.
• Extensive experience in the functional and phenotypic characterization of engineered cells with analytical techniques, including DNA sequencing, RT-qPCR, and Western Blots.
• Experience in a variety of bioassays on more physiologically relevant cellular models such as iPSCs, 3D-culture, co-culture, and primary cells.
• Competence in setting up and operating multimode plate readers (e.g., PHERAstar, CLARIOstar, FLIPR, EnVision) and automated liquid handlers (e.g., Echo, Dragonfly, Multidrop Combi, Bravo, BioTek Plate Washer, BlueWasher) for the development of 384- and/or 1536-well microtiter plate assays.
• Familiarity with software and statistical platforms necessary for analyzing large data sets, including Screener and Spotfire.

]]> Tue, 14 Apr 2026 00:00:00 EDT 0 In this vital role you will be part of the BEAM group providing scientific and technical expertise to support early Discovery Research through to later stage molecule optimization and late-stage selection of our pipeline of drug candidates. This position is an exciting opportunity to unlock the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics.

This role is well suited for someone who values hands-on lab work, enjoys working as part of a collaborative technical team, and is looking to build depth in protein-focused analytical workflows within a structured, on-site laboratory setting.

Responsibilities/Job Details: 

• Mass spectrometry scientist and analytical protein chemist with a consistent track record in biopharmaceutical protein support, scientific eminence and leadership and mentoring skills.
• Experience using analytical characterization techniques such as RPLC-MS for intact protein, reduced and subunit protein mass analysis. Experience using high-throughput MS like Rapidfire-MS is a plus.
• Experience with protein digestion and RPLC-MS/MS to map and characterize post translational modifications such as deamidation, isomerization and oxidation and associated data processing would be a plus.
• Experience generating, processing and using large LC-MS analytical data sets
• Experience with both ESI and MALDI techniques would be useful
• Communicate (verbal and in written) scientific concepts and results
• Work independently in advancing projects and studies within required deadlines
• Follow protocols and procedures, maintain accurate records in an electronic lab notebook

Basic Qualifications:

• Master’s degree and 2 years of biopharmaceutical Analytical Chemistry, Biochemistry or equivalent OR Bachelor’s degree and 4 years of biopharmaceutical Analytical Chemistry, Biochemistry or equivalent

Preferred Qualifications:

• Master’s degree and 2 years of biopharmaceutical Analytical Chemistry, Biochemistry or equivalent
• Knowledge of multiple mass spectrometric (MassHunter, XCalibur, MassLynx) chromatographic (ChemStation, Chromeleon) control software is preferred. Knowledge of Protein Metrics data processing software is a plus.
• Knowledge of statistical processing of data, including related software such as, but not limited to Excel, Spotfire or JMP is preferred

]]> Mon, 13 Apr 2026 00:00:00 EDT 0
An ideal candidate has a PhD degree in organic chemistry (or Master’s with 3 years experience) with lab experience in complex organic synthesis, e.g. natural products, organic methods, bench work at a pharmaceutical or fine chemical company and familiarity with standard organic characterization techniques (HPLC, LC-MS, NMR, Q-NMR).

The candidate will work as part of a drug process development team with a range of responsibilities including: independent synthesis of chemical intermediates and process impurities, reaction development, characterization of reaction profiles and isolated compounds, and commercial process development activities. The candidate will maintain an electronic laboratory notebook and computer files, participate in group and project meetings, and attend seminars. The candidate will work in a team environment collaborating with various colleagues in process development including process chemists and analytical chemists.

Basic Qualifications:

• Doctorate degree PhD OR PharmD OR MD and 2 years of Experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience

Preferred Qualifications:

• PhD in organic chemistry
• 2+ years of experience in the biopharmaceutical or pharmaceutical industry
• Broad knowledge of organic chemistry reactions and current scientific literature
• Laboratory skills including synthesis, purification, and characterization of organic, small molecules
• Analytical techniques including NMR, HPLC and Mass Spec
• Experience in reviewing and interpreting analytical data
• Demonstrated ability to work in a fast-paced, team environment
• Excellent presentation, written and verbal skills
• Knowledge of basic software including Microsoft Word, Excel, PowerPoint, and Outlook

]]> Mon, 06 Apr 2026 00:00:00 EDT 0

Supporting the product complaint system through the auditing of product complaint records and monitoring of complaint data in adherence with the Complaint policies and procedures, while assuring compliance to federal regulations.

Data analysis to support complaint team activities as needed.

Complete assessments to support complaint activities as needed.

Candidate will be responsible for ensuring complaints are accurately documented in the complaints data base and that the appropriate investigation has been performed, as well as determining whether the complaint is associated with an adverse event or medical device.

Candidate will be responsible for working cross functionally with other departments, contract partners, and call centers to resolve discrepancies/deficiencies.

Additional responsibilities include prioritizing complaints and understanding the importance of accurate data entry of complaints within the required timeframe, notifying appropriate parties upon audit completion of complaints, providing written communication to senior management and team members, and performing other duties as assigned by supervisor.

Complete assessments to support complaint activities as needed. Requirements / Qualifications:

• Doctorate degree OR Master’s degree & 1 years of experience directly related to the job OR Bachelor’s degree & 2 years of experience directly related to the job
• The candidate must be self-motivated, able to interface effectively with various levels, have careful attention to details and an understanding that accuracy and precision in all aspects of work are necessary.
• Candidate must be able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, and customer service skills to operate and deliver results in a matrix-managed GMP environment.
• Candidate must be well-organized, possess excellent oral and written communication skills, focus on process improvements, possess ability to manage a large number of complex projects simultaneously, and have the ability to function in a fast paced environment.
• Candidate must possess the ability to evaluate issues, make quality decisions and understand when to escalate, if necessary.
• Attention to detail
• Understanding of GDP
• Organizational skills
• Report management
• Complaints knowledge is a plus

]]> Thu, 02 Apr 2026 00:00:00 EDT 0 Senior Director of Bioconjugation will be responsible for managing key client account programs, and overseeing key research, development and production operations related to antibody-drug conjugates, conjugated vaccines, oligonucleotide-protein conjugates, and material products. This scientific leader will utilize personal extensive experiences and recognized expertise to lead the Bioconjugation department for the advancement of the science and technology in the business and accomplishment of the company goals.

Responsibilities:

• Manage key client account programs and maintain strong and lasting business relationships and oversee the chemistry process development from project ideation, bid defense, assignment, progression, and completion. Collaborate with the business development team to build a solid sales pipeline and have meaningful participation in all aspects of business.
• Lead the implementation, improvement and use of company systems withing Bioconjugation PD department such as but not limited to ELN, ERP, Chem Inventory, and training.
• Oversee the bioconjugation department operations and plan resources to successfully delivery client and company projects from project assignment, progression to completion.
• Manage technical input to GMP Batch Records and other Quality documents according to ICH and FDA guidelines.
• Manage the technology transfer inputs of PD processes into the GMP manufacturing suite and provide support during GMP operations as needed.
• Coordinate activities with QA/AMD/QC and Management for development of tox and GLP batches.
• Work with other teams to determine analytical methods and instruments needed to support PD and later GMP manufacturing.
• Partner with other departments on complex projects and collaborations.
• Propose key strategies for challenging projects with innovative solutions.
• Provide key leadership in the advancement of science and technology for the industry and business.
• Mentor group leaders for team building and career advancement.
• Perform at the highest professional standards.
• Communicate effectively with supervisors, colleagues and subordinates.
• Direct the team members to comply with company’s Safety/GMP/GLP/GDP guidelines and SOPs.
• Participate as a team player in all aspects of the company business.
• Keep up to date with EHS, cGMP, scientific, and technical developments.
• Evaluation of lab practices for continuous improvement.
• Provide assistance in laboratory design and process capabilities.
• Evaluate the team performance.
• Make hiring decisions through vigorous candidate screenings and interviews.

Requirements / Qualifications:

• PhD in Biochemistry or Bioengineering, and 10 years of extensive experience in bioprocessing, bioconjugate therapies and biopharmaceuticals
• Proven track record of drug discovery, development and manufacture with extensive CMC and GLP/GMP knowledge and experiences
• Excellent oral, written and interpersonal skills in scientific and business communications and presentations.
• Possess excellent problem-solving skills and demonstrate a thorough understanding of protein chemistry, protein handling, purification and characterization. 
• Ability to independently prioritize work assignments, and consistently demonstrate the ability to perform assigned tasks through rigorous data collection and applying analytical tests and instrumentation in the laboratory. 
• Travel between client sites (PA, CA and NC) as needed.

Physical Requirements:   

• Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. 
• Frequently lift and or move objects up to 30 pounds. 
• Stand/walk during entire length of shift. 
• Use arms, hands, and fingers to handle, feel or reach. 
• Ability to climb, balance, stoop, kneel, crouch, or crawl. 
• Visual abilities including near and far sight, color, peripheral vision, depth, and ability to focus.

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