Description
Senior Manager, Analytical Support [Chemistry]
Summary:
Reporting to the Senior Director of Analytical and Technical Support, this role Lead the activities of the Analytical & Technical Drug Product group which supports formulation development, drug product, raw materials, packaging, and device testing and release, related investigations, related methods and specifications, technical training, etc. Provides and supports a team approach for all activities within his/her groups in support of the development and manufacture of products, and their respective packages, for clinical and commercial distribution for the Company and its internal/external business partners. Provides analytical support for new and existing drugs entities and drug products manufactured and marketed by the Company and its internal/external business partners. Experience in performing and/or supporting drug discovery, characterization, and pre-formulation of large molecule pharmaceuticals, particularly protein and / lipid pharmaceuticals, is desired. Experience with aerosolization devices for inhalation is a plus. Provide technical assistance to QC, QA, Manufacturing, Materials Management, Clinical, and various offsite internal and external customers and business partners.
Responsibilities:
· Must be able to assess, determine improvements, and train staff on methods for drug product, APIs, raw materials, packaging components and devices.
· Must be able to design investigation studies to support the implementation of all types of analytical methods and testing equipment.
· Designs and oversees troubleshooting and investigation studies related to the group’s activities for production and laboratory issues.
· Must be able to design characterization and pre-formulation studies of protein and / lipid formulations.
· Must be able to understand synthetic pathways and degradation processes/pathways.
· Must possess a good working knowledge and understanding of advanced techniques required for structural analysis to support characterization of protein and/lipid formulations and their large molecule constituents.
· Tracks and trends release data for drug product, APIs, raw materials, packaging components and devices.
· Recommends specifications for impurities and degradation products, drug product, APIs and raw materials, as well as specifications for packaging components and devices.
· Approves and/or prepares technical reports/summaries for all work performed within his/her groups (e.g., testing protocols and reports, analytical methods, specifications, investigations, deviations, OOSs, etc.).
· Assesses alternate supplier methods and determines / oversees implementation / actions steps.
· Oversees the compendial review of all methods related to APIs, raw materials, packaging components and devices.
· Performs in-depth reviews (i.e., auditing) of laboratory notebooks and analytical records/reports to assure that calculations, content, references, etc. are technically correct and determines study/experiment disposition.
· Applies scientific knowledge and technical experience in designing and managing studies.
· Ensures all work within his/her groups is in accordance with cGMPs, USP/NF/BP/EP compendia, safety requirements, and company’s standard operating procedures.
· Be an active and effective project team leader within and outside the department.
· Oversee testing of APIs, raw materials, packaging and devices. Ensures testing and projects timelines are maintained.
· Develops professional skills to enhance job expertise and awareness of company policies for GMP, SOP and Safety Regulations.
· Determines the analytical instrumentation needs of the laboratory and offsite partners.
· Oversee and ensures the training of his/her staff.
· Must be able to work independently, in a proactive manner, on multiple projects, both on site and with off-site partners.
Like job titles:
Senior Scientist, Associate Director of Technical Services, Manager, Analytical and Technical Services
Key Words:
Aseptic, Environmental monitoring, FDA, cGMP, Sterile processing, endotoxin, excipients, quality control, microbiological monitoring, bioburden testing, WFI
Company:
Our Southeastern PA client is a biopharmaceutical company developing proprietary precision-engineered lung therapies for respiratory diseases. They have several premier products in late stage clinical development.
Our client offers an extremely competitive compensation program that includes attractive bonus and incentive. Successful candidates will enjoy a positive, progressive and exciting work environment. This opportunity will be extremely attractive to the individual seeking a collegial and entrepreneurial environment.
Requirements
Position Requirements:
· Ph.D. in Chemistry with 5 years of related, hands on lab experience in large molecules including protein/lipids or MS in Chem and 8 years or BS in Chem and 10 years.
· Pharmaceutical quality control or analytical development laboratory setting performing progressively more responsible lab work
· 2 plus years of supervisory experience with a small group
