Biotech Partners | Biotech Executive Search

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Quality Assurance Manager

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  • Date Posted May 18, 2020
  • Location Cleveland, Ohio
  • Job Type Direct Hire
  • Job ID 2113

We are working with an industry leading CRO who is looking for an experienced professional to join them in a collaborative approach on the journey of getting new drugs to market.

Our client is seeking a Quality Assurance Manager in Cleveland, Ohio!

Our client is a CRO that uses the latest technology to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. They hold an excellent employee-retention rate and offer competitive salaries and bonus structures. This position allows for upward mobility in the future, provides regular training and promotes a teamwork-driven environment. This position will develop, manufacture and characterize small molecule drug substances while complying with GLP/GMP regulations. The manager will provide oversight for the company’s quality standards and systems, making improvements when appropriate.

Specific Responsibilities:

  • Review/Approve quality documentation (batch records, project protocols, validation plans, quality agreements and associated analytical data)
  • Responsible for reviewing/approving deviations, the post-investigative report and the corrective/preventative actions to implement going forward
  • Conduct regular audits to ensure all compliance and standards are met
  • Responsible for enforcing Good Manufacturing Practices (GMP) and supplier/material qualification
  • Manage study data related to the company’s quality standards
  • Monitor change control, deviations, and CAPAs through the QMS database
  • Responsible for three to five direct reports
  • Responsible for archives, document control and implementing a training program
  • Manage inspections by regulatory governing bodies (FDA/EMA)

Qualifications:

  • BS in a technical field or a minimum of 7-10 years of experience of in the pharmaceutical/ biotech industry
  • Five or more years in QA manufacturing and small molecule characterization
  • Knowledge of drug development process
  • Familiarity with data integrity and qualifying equipment
  • Experience managing multiple priorities and quality assurance staff

Qualified Candidates, Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

Senior Process Chemist (2)

by

  • Date Posted May 18, 2020
  • Location Cleveland, Ohio
  • Job Type Direct Hire
  • Job ID 2111

We are working with an industry-leading CRO who is looking for an experienced professional to join them in a collaborative approach on the journey of getting new drugs to market.

Our client is seeking a Senior Process Chemist in Cleveland, Ohio!

Our client is a CRO that uses the latest technology to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. They hold an excellent employee-retention rate and offer competitive salaries and bonus structures. This position allows for upward mobility in the future, provides regular training and promotes a teamwork-driven environment.

Specific Responsibilities:

  • Hands-on laboratory chemical development of robust, safe and scale-able processes for operation and plant equipment
  • Lead one or more synthesis projects and provide support to other projects as required
  • Provide strong and consistent support for pilot plant projects
  • Assist in analysis of client RFPs and provide technical input to generation of proposals
  • As project leader, serve as primary contact with the client, write project updates and chair teleconferences
  • Routinely assumes the primary investigator /project leader role
  • Analyzes synthetic routes and processes provided by clients, obtains accurate process data, solves challenging synthetic chemistry and processing problems as required to meet client goals
  • Has a working knowledge of cGMP regulations, process scale-up requirements, and process chemistry techniques
  • Has a working knowledge of Kilolab and pilot plant operations
  • Maintains strong working relationship with other departments (Analytical, PD&E, Regulatory Affairs, Client Services) and develops an understanding of the work done by these departments
  • Supervises and mentors scientific staff.
  • Proficient in standard analytical techniques (TLC, NMR, HPLC, LC/MS, GC, etc.)

Qualifications:

  • PhD level in Organic Chemistry
  • 5+ years of experience in pharmaceutical process development for scale up of intermediates and API into Kilolab and pilot plant facilities
  • Experience in a CRO or CMO environment is desirable

Qualified Candidates, Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.