Project Manager, Quality Control

Employer
Bachem
Location
Torrance, CA
Posted
Sep 23, 2021
Ref
688511901
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Associate Degree
Position Type
Full time

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

In order to continue our organic growth, we are constantly looking for talent.

The Quality Control Project Manager fulfills a critical role in the active pharmaceutical ingredient (API) (final product) manufacturing operations. This individual manages and coordinates New Chemical Entities (NCE) and generics API (Active Pharmaceutical Ingredients) projects for the QC department by interfacing with the customer and multiple departments. The Quality Control Project Manager should have a thorough understanding of analytical chemistry methodologies, quality control laboratory work flows, laboratory operations and project management. This role serves to represent the Quality unit in CMC development and internal/external project calls.

Your Tasks:

  • Communicate effectively and coordinate flow of information within Bachem and between Bachem and customers
  • Provides timely responses to internal and external inquiries
  • Ability to work and communicate with different associates within the company to ensure timely completion of project deliverables
  • Has a sense of urgency around project deliverables and functions well in a fast-paced team environment
  • Coordinate project-specific analytical activities between production, R&D, QC, QA, RA and PM (Project Management)/BD (Business Development)/Sales
  • Responsible for identifying project risks regarding filing strategy and initiation of measures to reduce them
  • Ensure compliance and continuous improvement of Bachem America’s CMC development concept
  • Ensure the common understanding of all project team members of project goal and purpose regarding QC issues
  • Fulfil the role of point person for project team members regarding the progress of project-specific activities by the team members
  • Responsible for preparing presentations for customer visits and conference calls and for preparation of internal meeting agenda and implementation
  • Responsible for updating project status to the project sponsor
  • Support QC department management with:
    • Creation of quotes for service orders
    • Control and approval of project related documents
    • Customer Audits and lab tours
    • Investigations
  • Ability to analyze laboratory operations and metrics to identify areas of opportunity for improvement
  • Contribute to finding efficiencies in laboratory operations

Your Profile:

  • Minimum B.S. in Science (Chemistry, Biochemistry, Biology or similar) field
  • 2-5 years pharm/biotech experience (laboratory, QA/QC or cGMP manufacturing)
  • 1-3 years of project management experience
  • 1-2 years in customer-facing role, such as sales, consulting, or Project Management in the pharma, biotech or medical device industry
  • In-depth knowledge and understanding of Analytical Chemistry specifically chromatography, mass spectrometry and method development/validations
  • Excellent computer/ software know-how, including MS Office suite and software for project management and statistical analysis
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment with internal and external customers
  • Ability to communicate in a proactive and solution-focused manner, including identifying risks and keeping management aware of potential issues
  • Detail-oriented and extremely organized with the ability to troubleshoot and resolve problems
  • Communicate effectively and ability to function well in a diverse team environment

Preferred:

  • Master’s Degree in Analytical Chemistry or related science field and a minimum of 3 years of Project Management experience
  • Experience with peptide chemistry or pharmaceutical manufacturing
  • PMP Certification