Emery Pharma
Associate Director- Mass Spectrometry, Biopharmaceuticals
Emery Pharma, California, Missouri, United States, 65018
Associate Director- Mass Spectrometry, Biopharmaceuticals
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Position Overview The Associate Director- Mass Spectrometry, Biopharmaceuticals position will be responsible for helping to perform method development, feasibility, qualification and/or validation of methods in support of large molecule biopharmaceutical products using primarily High Resolution Mass Spectrometry. The role will involve performing mass spectrometry-based characterization of various biologic drugs on behalf of sponsors, including but not limited to mAbs, ADCs, BiTEs, etc. This individual may assist with the development of proposals for clients in collaboration with the Business Development team, as well as overseeing several aspects of lab operations including design and implementation of mass spectrometry strategies for the characterization, structural elucidation, and quality assessment of biopharmaceuticals, including mAbs, recombinant proteins, and other complex biological molecules within R&D and GLP/cGMP environment.
We are seeking an experienced scientist, who has in-depth knowledge and specific understanding of drug development of Biologic drugs. This individual would provide strategic direction to the project teams and support Emery Pharma’s Analytical Chemistry Business Unit and Management. You will play a crucial role in advancing our biopharmaceutical development and characterization programs through the application of cutting-edge mass spectrometry techniques in support of our expanding pipeline of Client projects. This position will report directly to the Director of Chemistry.
Essential Job Functions
Perform method development, feasibility, qualification and/or validation of methods in support of large molecule biopharmaceutical products using primarily High Resolution Mass spectrometry
Conduct protein analysis including primary structure and interpretation of secondary, tertiary, and quaternary structure data analysis
Peptide mapping analysis including detecting and characterizing PTMs (profiling and site mapping) and sequence confirmation
Glycan analysis including profiling, quantification, and elucidation
Protein quantification using enzyme-linked immunosorbent assay (ELISA) is a plus.
Troubleshoot method and instrument challenges
Consults with clients on scientific needs, answering questions and providing regular updates on project status
Works in collaboration with Business Development team to outline scope of work, provide budgetary input, set project timelines, and anticipate technical challenges for each project
Participates in client meetings and preliminary discussions regarding client needs, provides technical knowledge to help outline project requirements and answer technical questions
Establishes the design and manages the conduct of studies in compliance with the protocol/amendments/planned changes, SOPs, and all applicable regulatory requirements; i.e., GLP, GCP, ICH, etc. (some familiarity is a plus)
Serves as a single point of contact for project directors and scientific team after project initiation
Organizes and communicates complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds
Reviews and approves reports, or reporting of results, within study timelines, and ensures any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurate
Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities
Work interactively and cooperatively with all functions of the company and with senior staff to help achieve the company’s vision
May supervise team members within work group
These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel
Requirements
Ph.D. in Analytical Chemistry or very closely related field is required
Experience with protein sciences, biologic drugs, and large molecule characterization
1-3 years of pharmaceutical industry experience
Must be skilled in operation of chromatographic data acquisition and processing software packages including BioPharma finder, Compound Discoverer, etc.
Position is onsite full-time, Monday - Friday 9:00 am - 5:00 pm
Strong Analytical background, as well as some knowledge of cGMPs, ICH, relevant FDA guidelines, and experience in writing relevant regulatory submissions
Candidate should be a strong team player with excellent oral and written communication skills and with a demonstrated ability to interpret data, troubleshoot, and suggest next steps
Appropriate technical experience of relevant laboratory techniques within a regulated environment
Proficiency in hands on analytical work while managing internal and external activities
Exhibit strong technical skills and the ability to critically evaluate raw data and results without supervision
Contact Us We are prepared to offer the candidate a sign-on bonus. Emery Pharma has a competitive compensation and benefit package including 90% of health, dental, and vision premiums, 401k retirement plan with company contribution, and monthly performance bonuses. Company offers a paid/flexible time off policy.
Please send resume /C.V. with a cover letter to: careers@emerypharma.com
Emery Pharma is an equal opportunity employer.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Business Development and Sales
Industries
Research Services
Note: This refined description preserves the essential information from the original posting while improving structure and accessibility.
#J-18808-Ljbffr
Position Overview The Associate Director- Mass Spectrometry, Biopharmaceuticals position will be responsible for helping to perform method development, feasibility, qualification and/or validation of methods in support of large molecule biopharmaceutical products using primarily High Resolution Mass Spectrometry. The role will involve performing mass spectrometry-based characterization of various biologic drugs on behalf of sponsors, including but not limited to mAbs, ADCs, BiTEs, etc. This individual may assist with the development of proposals for clients in collaboration with the Business Development team, as well as overseeing several aspects of lab operations including design and implementation of mass spectrometry strategies for the characterization, structural elucidation, and quality assessment of biopharmaceuticals, including mAbs, recombinant proteins, and other complex biological molecules within R&D and GLP/cGMP environment.
We are seeking an experienced scientist, who has in-depth knowledge and specific understanding of drug development of Biologic drugs. This individual would provide strategic direction to the project teams and support Emery Pharma’s Analytical Chemistry Business Unit and Management. You will play a crucial role in advancing our biopharmaceutical development and characterization programs through the application of cutting-edge mass spectrometry techniques in support of our expanding pipeline of Client projects. This position will report directly to the Director of Chemistry.
Essential Job Functions
Perform method development, feasibility, qualification and/or validation of methods in support of large molecule biopharmaceutical products using primarily High Resolution Mass spectrometry
Conduct protein analysis including primary structure and interpretation of secondary, tertiary, and quaternary structure data analysis
Peptide mapping analysis including detecting and characterizing PTMs (profiling and site mapping) and sequence confirmation
Glycan analysis including profiling, quantification, and elucidation
Protein quantification using enzyme-linked immunosorbent assay (ELISA) is a plus.
Troubleshoot method and instrument challenges
Consults with clients on scientific needs, answering questions and providing regular updates on project status
Works in collaboration with Business Development team to outline scope of work, provide budgetary input, set project timelines, and anticipate technical challenges for each project
Participates in client meetings and preliminary discussions regarding client needs, provides technical knowledge to help outline project requirements and answer technical questions
Establishes the design and manages the conduct of studies in compliance with the protocol/amendments/planned changes, SOPs, and all applicable regulatory requirements; i.e., GLP, GCP, ICH, etc. (some familiarity is a plus)
Serves as a single point of contact for project directors and scientific team after project initiation
Organizes and communicates complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds
Reviews and approves reports, or reporting of results, within study timelines, and ensures any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurate
Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities
Work interactively and cooperatively with all functions of the company and with senior staff to help achieve the company’s vision
May supervise team members within work group
These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel
Requirements
Ph.D. in Analytical Chemistry or very closely related field is required
Experience with protein sciences, biologic drugs, and large molecule characterization
1-3 years of pharmaceutical industry experience
Must be skilled in operation of chromatographic data acquisition and processing software packages including BioPharma finder, Compound Discoverer, etc.
Position is onsite full-time, Monday - Friday 9:00 am - 5:00 pm
Strong Analytical background, as well as some knowledge of cGMPs, ICH, relevant FDA guidelines, and experience in writing relevant regulatory submissions
Candidate should be a strong team player with excellent oral and written communication skills and with a demonstrated ability to interpret data, troubleshoot, and suggest next steps
Appropriate technical experience of relevant laboratory techniques within a regulated environment
Proficiency in hands on analytical work while managing internal and external activities
Exhibit strong technical skills and the ability to critically evaluate raw data and results without supervision
Contact Us We are prepared to offer the candidate a sign-on bonus. Emery Pharma has a competitive compensation and benefit package including 90% of health, dental, and vision premiums, 401k retirement plan with company contribution, and monthly performance bonuses. Company offers a paid/flexible time off policy.
Please send resume /C.V. with a cover letter to: careers@emerypharma.com
Emery Pharma is an equal opportunity employer.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Business Development and Sales
Industries
Research Services
Note: This refined description preserves the essential information from the original posting while improving structure and accessibility.
#J-18808-Ljbffr