Analytical Method Development Manager

Posting Date 2 weeks ago(9/16/2020 5:03 PM)
Requisition ID
2020-7845
Job Location(s)
Pittsburgh PA United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Biomedical/Biotechnology

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Analytical Method Development Manager at Cook MyoSite is responsible for overseeing all departmental functions to support analytical method development for cell therapy products and related research projects.

Responsibilities

• Oversee analytical method development department systems, resources, personnel, and projects
• Set departmental objectives and priorities and work with executive management to align departmental work with company objectives and priorities
• Ensure resources are available and efficiently utilized to perform departmental responsibilities
• Participate in the hiring, development, and performance management of personnel
• Coach and mentor direct reports
• Maintain open communication with other departments for realization of departmental and company objectives
• Serve as responsible party for process development in interdepartmental systems, including review and approval of quality system documentation

• Support all areas of analytical method development, including discovery, design, development, transfer, qualification, validation, and lifecycle management
• Assist in project planning and execution, including experimental design, laboratory work, data analysis, interpretation of results, formulation of recommendations, preparation of deliverables
• Ensure the accuracy and completeness of departmental reports and presentations
• Act as a resource to provide technical and scientific support to department and company projects
• Develop technical and scientific expertise and capabilities necessary for project management and completion

Qualifications

• Master's degree in Life Sciences or Engineering or undergraduate degree in Life Sciences or Engineering plus 2 years of direct, relevant leadership experience in a scientific research role
• Experience leading projects and managing project teams and/or related experience; formal management experience preferred
• Experience guiding research efforts of others
• Experience in analytical method and/or product development
• Extensive experience with relevant laboratory techniques for cell characterization, material testing, pharmacopeia testing, and/or relevant technical areas

• Experience with cGMP and related regulations associated with biologic/pharmaceutical product manufacturing and/or regenerative medicine

• Ongoing commitment to expanding knowledge, job skills and abilities
• Excellent problem-solving skills

• Ability to think critically and exercise sound judgment in conducting, reviewing, and interpreting scientific research
• Ability to effectively collaborate and communicate with other departments and cross-functional teams
• Knowledge of analytical method development and validation, and related regulations associated with biologic/pharmaceutical product manufacturing
• Excellent technical writing skills
• Effective interpersonal skills and ability to lead complex project teams
• Effective leadership skills, including ability to motivate and coach team members

• Proficient knowledge of Microsoft Office software, and other general office equipment

 

Physical Requirements: 

• Lab / Non-Production Setting: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

• Ability to conduct and hear ordinary conversation and telephone communication.

• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.

• Ability to work under specific time constraints.

• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.

• Visual and manual acuity for working with computers and equipment.

• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting.

• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.

• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.

• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis.

• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.

 

 

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