Pharmaceutical R&D Analytical Team Leader
Velesco Pharma is a contract research and manufacturing organization providing formulation, analytical and cGMP clinical supplies to clients in the pharmaceutical/biotech industry. Velesco is a high growth organization founded and staffed by pharmaceutical industry veterans. The successful candidate will be working in a dynamic flexible environment with an opportunity to learn and take on greater responsibility.
Velesco Pharma is recruiting an individual with extensive experience in the development, validation, and troubleshooting of analytical methods in support of drug product formulations and who can be a leader in our analytical development laboratory.
This position will be based in Velesco Pharma’s research and cGMP Laboratories in Plymouth Michigan.
Minimum of 8 years’ experience in a pharmaceutical sciences research and development analytical laboratory is required with focus on early, mid, and late stage method development and validation in support of cGMP drug products and research projects. The candidate’s primary responsibility will be to develop and execute experimental plans, manage a small team of analytical scientists, and communicate results clearly and efficiently.
Furthermore, the candidate should be familiar with drafting and executing methods, SOPs, stability protocols, validation protocols, and reports and be familiar with analytical specifications appropriate for the phase of development.
Essential skills should include:
Experience with developing pharmaceutical drug product analytical methods, and deep understanding of drug product method requirements for early stage analyses.
Experience communicating experimental results clearly and concisely.
Experience training, mentoring, and developing junior scientists.
Familiarity with operating, maintaining, and troubleshooting Agilent HPLC systems running Agilent software and Empower.
Experience with dissolution, viscosity, Karl Fischer, osmometry, disintegration, and compendia methods.
Familiarity with cGMP regulations, ICH, EU regulations, especially pertaining to stability and method validation.
Perform job duties with little to no direction from supervisor. Able to navigate ambiguity and changing priorities.
Accustomed to writing Experimental plans, SOPs, Reports, as well as high quality lab notebook documentation.
Additional desired skills or experience:
Experience working directly with a Pharmaceutical Sciences development team, preferably with experience as analytical lead reporting to the team.
Experience with and knowledge of formulation development support and formulation development processes.
Experience with communicating with clients and supporting client visits
Familiarization with Instrument purchase, installation, operation, and performance qualifications. Experience with preventive maintenance and calibration of instruments.
Ability to work in a research environment where analytical research and development and quality control intersect.
Ability to work with third party labs for method transfer
Experience participating in quality audits of the GMP labs and stability programs
Ability to maintain GMP labs and stability program as audit ready
Experience training colleagues in method development, validation, and SOPs
The candidate must be self-motivated, possess good interpersonal skills, and have ability to independently handle a diverse workload of projects with unique client requirements and timelines. The candidate will work in a fast changing environment and needs good judgment and awareness to recognize and solve laboratory/data issues. The individual must exhibit good writing, communication and time-management skills and be proficient in Microsoft Word, Excel, Outlook, and similar programs. Ability and willingness to work in a team environment and participate in team activities is a must.
BS or MS Degree including 2-3 years supervising and developing more junior staff in Chemistry or related field.
Salary: Competitive base salary plus bonus
Benefits: Health & Dental Insurance, 401K
Interested candidates please submit your resume to email@example.com