Manager/Sr Manager, Biostatistics (QC)

Location
Austin, TX, USA
Posted
Sep 04, 2019
Ref
86242
Required Education
Masters Degree/MBA
Position Type
Full time
Company Description:

Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

Molecular Templates is seeking a highly-skilled and dynamic professional to lead statistical analysis for Quality Control, Manufacturing Development, Production and regulatory filings. This Manager will evaluate the stability program data to support specification development and analysis. This role will also author and review technical protocols and reports, as applicable. May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma). This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently and to collaborate with cross-functional teams, vendors and contractors.

Job Responsibilities will include:
  • Evaluate statistical data of ongoing stability testing
  • Review method developments, qualifications, and validations for statistical analysis
  • Analyze statistical data to support specification development and analysis
  • Analyze in-process and completed manufacturing data to support long term manufacturing process improvement and scale up activities.


Qualifications:
  • MS degree plus 4+ years of relevant industry experience; or PhD plus 2+ years of relevant industry experience. Degree emphasis in Life Sciences, Chemical Engineering, Biochemical Engineering, Biochemistry
  • Minimum of six (6) years of industry experience in pharmaceutical or biotechnology area focused managing statistical analysis for Quality Control and Manufacturing Development
  • Comprehensive knowledge of cGMP regulation applicable to the FDA and comparable international regulatory agencies
  • Knowledge of general principles related to mathematics, statistics and data management analysis
  • Experience with protein-based therapeutics, required
  • Demonstrated experience creating analytical development plans and experiment design and establishing product specifications and critical quality attributes and limits
  • Experience in managing quality systems and program management, required
  • Excellent written and verbal communication skills
  • Excellent computer skills
  • Excellent technical, analytical and problem-solving skills
  • Excellent organizational and multi-tasking skills
  • Ability to provide thought-leadership and scientific insight for method development, data analysis and other GMP QC activities
  • Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment
  • Ability to work collaboratively with cross-functional teams and contractors in order to drive results and meet company objectives
  • Ability to function independently and exercise good judgement, as well as in a team-based environment


Reporting Structure:

This position currently has supervisory responsibilities. This position reports to QC Director.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com