Scientist, Analytical Sciences & Technology
Salary undisclosed
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We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World.
A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.
Position Summary
The Scientist within the Analytical Science and Technology team is responsible for executing analytical method lifecycle activities for the testing of raw materials, excipients, biologics and other modalities in-process, drug substance, and drug product samples. The candidate will be responsible for the implementation of analytical methods for a variety of instrumentation and techniques to support early-stage product development through commercialization efforts. The candidate will perform non-GMP testing, non-GMP stability testing, equipment qualification, reference standard qualification, and comparability studies.
Duties & Responsibilities
May require supervisory responsibility of up to 5-7 direct reports. Demonstrated leadership experience is preferred.
Travel
This position may require up to 10% of domestic and/or international travel.
Target Bonus
10%
New York Pay Range: $76,000 USD - $113,000 USD
Work Location
East Syracuse, NY
We are an Equal Employment Opportunity (“EEO”) Employer.
We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities! If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!
A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.
Position Summary
The Scientist within the Analytical Science and Technology team is responsible for executing analytical method lifecycle activities for the testing of raw materials, excipients, biologics and other modalities in-process, drug substance, and drug product samples. The candidate will be responsible for the implementation of analytical methods for a variety of instrumentation and techniques to support early-stage product development through commercialization efforts. The candidate will perform non-GMP testing, non-GMP stability testing, equipment qualification, reference standard qualification, and comparability studies.
Duties & Responsibilities
- Perform analytical method development, qualification, validation, and method transfer activities, developing subject matter expertise with protein biotherapeutic test methods used for structural elucidation and physicochemical characterization of biologics and other modality products.
- Leverage a strong understanding of the drug substance process to lead analytical activities and testing of upstream and downstream study samples for manufacturing process development, characterization, and process improvements.
- Document experimental results and perform data analysis, interpretation, and trending.
- Design, author, and review standard operating procedures, methods, protocols, reports, change controls, regulatory submission supporting documentation (i.e., specifications, reference standard, extended characterization, product stability/shelf-life), and other associated scientific technical documents.
- Optimize and lead technical transfers to quality control and serve as an analytical expert for transfer and validation activities, investigations, method troubleshooting, and mentoring junior staff.
- Lead continuous improvement initiatives through identifying opportunities for technical advancements and implementing new analytical technologies including the acquisition, upgrade, and qualification of instruments.
- Interact with global Health Authorities and clients for site inspections and CMC review of regulatory filings (IND, IND amendment, BLA, MAA, PAS, etc.) and prepare inquiry responses as required.
- Perform routine laboratory activities including sample management, instrument maintenance and calibration, inventory and ordering of supplies, general housekeeping, and other related activities.
- Work in a diverse group environment while focusing on inclusivity and safety to produce high quality, compliant results.
- B.Sc./B.Eng. in Biology, Chemistry, Biotechnology, or equivalent area of related study with 5-7 years, M.Sc./M.Eng. with 2-4 years, or Ph.D. with 0-2 years, of industry experience in biologic/protein analytics.
- Experience across the analytical method lifecycle in protein biotherapeutics for a variety of methodologies and instrumentation used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and various other analytical techniques (i.e., qPCR, ELISA, CE-SDS, iCIEF, SDS-PAGE, UV-VIS, western blotting, mass spectrometry, and cell-based assays) is required.
- Working knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, compendial requirements, and experimental statistical design/data analysis is required.
- Experience authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is required.
- Experience developing bridging studies between new and existing methods, method comparability studies, and product comparability studies required to support CMC changes is preferred.
- Experience leading analytical method change controls within a Quality Management System and ensuring all required test data and reports are available to support and justify the change(s) is preferred.
- Experience defining analytical control strategy, coordinating the specifications development process, preparing the specification package documents, and driving the process for internal and regulatory approval of the specifications is desired.
- Ability to interpret technical data and results to draw appropriate conclusions, apply risk-based quality principles, and identify logical next steps to ensure good scientific, compliance and regulatory outcomes.
- Strong verbal, written, presentation, and interpersonal communication skills with ability to clearly articulate scientific objectives and results to lead discussions, build alignment, and make recommendations in multidisciplinary meetings.
- Ability to prioritize, manage team priorities/resources, and complete project deliverables within given timelines.
- Organized, detail oriented, and proficient in writing formal reports, documents, and technical presentations.
- Aptitude as a functional mentor/technical point of contact and ability to effectively train others.
- Demonstrated history of continuous improvement.
- The role is a combination of laboratory and office based work.
- The laboratory work requires appropriate levels of personal protective equipment (PPE). The role may require contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics. Powdered materials and high temperature liquids and solids may also be handled. Use of a respirator may be required.
- Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, sitting, kneeling, climbing on stepstools, and reaching may be required. Repetitive use of arms/hands/wrists and grasping may be required.
- The role may require unassisted lifting (not to exceed 50 lbs.).
- Position is primarily laboratory and office based with occasional work in a classified GMP manufacturing environment.
- Dynamic, fast-paced, interactive, and entrepreneurial environment.
- Position is a team and project-based position that may require occasional shift work, weekends, and holidays
May require supervisory responsibility of up to 5-7 direct reports. Demonstrated leadership experience is preferred.
Travel
This position may require up to 10% of domestic and/or international travel.
Target Bonus
10%
New York Pay Range: $76,000 USD - $113,000 USD
Work Location
East Syracuse, NY
We are an Equal Employment Opportunity (“EEO”) Employer.
We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities! If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!
We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World.
A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.
Position Summary
The Scientist within the Analytical Science and Technology team is responsible for executing analytical method lifecycle activities for the testing of raw materials, excipients, biologics and other modalities in-process, drug substance, and drug product samples. The candidate will be responsible for the implementation of analytical methods for a variety of instrumentation and techniques to support early-stage product development through commercialization efforts. The candidate will perform non-GMP testing, non-GMP stability testing, equipment qualification, reference standard qualification, and comparability studies.
Duties & Responsibilities
May require supervisory responsibility of up to 5-7 direct reports. Demonstrated leadership experience is preferred.
Travel
This position may require up to 10% of domestic and/or international travel.
Target Bonus
10%
New York Pay Range: $76,000 USD - $113,000 USD
Work Location
East Syracuse, NY
We are an Equal Employment Opportunity (“EEO”) Employer.
We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities! If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!
A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.
Position Summary
The Scientist within the Analytical Science and Technology team is responsible for executing analytical method lifecycle activities for the testing of raw materials, excipients, biologics and other modalities in-process, drug substance, and drug product samples. The candidate will be responsible for the implementation of analytical methods for a variety of instrumentation and techniques to support early-stage product development through commercialization efforts. The candidate will perform non-GMP testing, non-GMP stability testing, equipment qualification, reference standard qualification, and comparability studies.
Duties & Responsibilities
- Perform analytical method development, qualification, validation, and method transfer activities, developing subject matter expertise with protein biotherapeutic test methods used for structural elucidation and physicochemical characterization of biologics and other modality products.
- Leverage a strong understanding of the drug substance process to lead analytical activities and testing of upstream and downstream study samples for manufacturing process development, characterization, and process improvements.
- Document experimental results and perform data analysis, interpretation, and trending.
- Design, author, and review standard operating procedures, methods, protocols, reports, change controls, regulatory submission supporting documentation (i.e., specifications, reference standard, extended characterization, product stability/shelf-life), and other associated scientific technical documents.
- Optimize and lead technical transfers to quality control and serve as an analytical expert for transfer and validation activities, investigations, method troubleshooting, and mentoring junior staff.
- Lead continuous improvement initiatives through identifying opportunities for technical advancements and implementing new analytical technologies including the acquisition, upgrade, and qualification of instruments.
- Interact with global Health Authorities and clients for site inspections and CMC review of regulatory filings (IND, IND amendment, BLA, MAA, PAS, etc.) and prepare inquiry responses as required.
- Perform routine laboratory activities including sample management, instrument maintenance and calibration, inventory and ordering of supplies, general housekeeping, and other related activities.
- Work in a diverse group environment while focusing on inclusivity and safety to produce high quality, compliant results.
- B.Sc./B.Eng. in Biology, Chemistry, Biotechnology, or equivalent area of related study with 5-7 years, M.Sc./M.Eng. with 2-4 years, or Ph.D. with 0-2 years, of industry experience in biologic/protein analytics.
- Experience across the analytical method lifecycle in protein biotherapeutics for a variety of methodologies and instrumentation used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and various other analytical techniques (i.e., qPCR, ELISA, CE-SDS, iCIEF, SDS-PAGE, UV-VIS, western blotting, mass spectrometry, and cell-based assays) is required.
- Working knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, compendial requirements, and experimental statistical design/data analysis is required.
- Experience authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is required.
- Experience developing bridging studies between new and existing methods, method comparability studies, and product comparability studies required to support CMC changes is preferred.
- Experience leading analytical method change controls within a Quality Management System and ensuring all required test data and reports are available to support and justify the change(s) is preferred.
- Experience defining analytical control strategy, coordinating the specifications development process, preparing the specification package documents, and driving the process for internal and regulatory approval of the specifications is desired.
- Ability to interpret technical data and results to draw appropriate conclusions, apply risk-based quality principles, and identify logical next steps to ensure good scientific, compliance and regulatory outcomes.
- Strong verbal, written, presentation, and interpersonal communication skills with ability to clearly articulate scientific objectives and results to lead discussions, build alignment, and make recommendations in multidisciplinary meetings.
- Ability to prioritize, manage team priorities/resources, and complete project deliverables within given timelines.
- Organized, detail oriented, and proficient in writing formal reports, documents, and technical presentations.
- Aptitude as a functional mentor/technical point of contact and ability to effectively train others.
- Demonstrated history of continuous improvement.
- The role is a combination of laboratory and office based work.
- The laboratory work requires appropriate levels of personal protective equipment (PPE). The role may require contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics. Powdered materials and high temperature liquids and solids may also be handled. Use of a respirator may be required.
- Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, sitting, kneeling, climbing on stepstools, and reaching may be required. Repetitive use of arms/hands/wrists and grasping may be required.
- The role may require unassisted lifting (not to exceed 50 lbs.).
- Position is primarily laboratory and office based with occasional work in a classified GMP manufacturing environment.
- Dynamic, fast-paced, interactive, and entrepreneurial environment.
- Position is a team and project-based position that may require occasional shift work, weekends, and holidays
May require supervisory responsibility of up to 5-7 direct reports. Demonstrated leadership experience is preferred.
Travel
This position may require up to 10% of domestic and/or international travel.
Target Bonus
10%
New York Pay Range: $76,000 USD - $113,000 USD
Work Location
East Syracuse, NY
We are an Equal Employment Opportunity (“EEO”) Employer.
We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities! If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!