Project Manager

Employer
Bachem
Location
Torrance, CA, US
Posted
Sep 28, 2020
Ref
612315401
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The Project Manager (PM) is responsible for the coordination and proactive management of ongoing active pharmaceutical ingredient (API) manufacturing campaigns for Bachem customers in the biotechnology and pharmaceutical industries. The PM reports into Group Leader or Director and liaises externally with the customers as well as internally with Bachem Sales and site-specific (Torrance or Vista, CA) Operations (QC, QA, Logistics, and Production) teams to ensure that the clients' milestones and deliverables are met.

Your Tasks:

  • Proactively and simultaneously manage multiple (5+) generic and new chemical entity (NCE) drug substance manufacturing projects at Bachem Americas for non-GMP, clinical and commercial GMP use
  • Ensure that project deliverables and timelines are met as stipulated in customer purchase orders and agreements/contracts (Non-Disclosure Agreement, Master Supply Agreement, Quality Agreement, Developmental Agreement, Statement of Work)
  • Once project is completed, perform closing activities such as shipping, storage, and invoicing of product
  • Interface with project management functions at other Bachem manufacturing sites (Vista, CA and Bubendorf, Switzerland) to track progress of projects ordered within the Americas
  • Consistently communicate timely and project progress updates and/or issues to customers via email and teleconferences
  • Effectively manage customer review, approval and delivery (where applicable) of manufacturing-related documents (batch records, analytical method and validation protocols/reports, CofA's, and release specifications)
  • Facilitate in project-related discussions both internally and externally and generate meeting notes and action items
  • Serve as liaison between customer contacts and technical staff at Bachem manufacturing sites
  • Provide feedback internally on project-related proposal requests as needed
  • Update Enterprise Resource Planning (ERP) and CRM software to reflect real-time project status/requirements
  • Schedule, organize, and document customer visits (technical and quality/audit-related) to manufacturing sites
  • Collaborate with Contract Manager to ensure the feasibility of compliance within all contracts and agreements
  • Maintain close communication with Sales Team to ensure they are kept informed on project interactions with customers
  • Communicate monthly project status, closing, and financials to Bachem upper management
  • Participate in sales process whenever needed
  • Assist/train sales force and other key personnel in manufacturing capabilities and associated services
  • Special projects will be assigned on occasion
  • Travel may be required as business demands dictate


Your Profile:

  • Minimum B.S. in Science (Chemistry, Biochemistry, Biology or similar) field
  • 3-5 years pharm/biotech experience (laboratory, laboratory-related, and/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
  • Ability to understand financial aspects of customer accounts (Payment terms, pre-payment requirements, forecasting) Excellent computer/system skills, especially MS Office, CRM (Salesforce), Document Control (Master Control), Document-sharing (SharePoint, ShareFile), ERP (SAP), Online and video-conferencing meetings (Skype); MS Project
  • Excellent written and oral communication skills
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Experience facilitating external and internal team calls and onsite visits to manufacturing sites and capturing required notes and action items
  • Ability to communicate in a proactive and solution-focused manner, including keeping management and stakeholders aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently and manage one's time
  • Communicate effectively and ability to function well in a cross-functional team environment


Preferred:

  • M.S. or Ph.D. in Science (Chemistry, Biochemistry, Biology, Bioengineering, or similar) field or MBA
  • PMP certification
  • Drug substance peptide, small molecule, oligonucleotide, or recombinant protein manufacturing experience
  • FDA and/or Global Regulatory and compliance experience
  • CMO or CRO experience
  • Knowledge of contracts and agreements (NDA's, Supply Agreements, Quality Agreements, Request for Proposals) to ensure they are adhered to during project execution
  • Knowledge of Chemistry, Manufacturing, and Controls (CMC) documents having to do with IND and NDA filings and API development
  • Knowledge of packaging and shipping of drug substances domestically and/or internationally and associated Incoterms
  • Familiarity with drug substance characterization analysis (HPLC, UPLC, LC-MS, MS, GC-MS, AAA, CHN) for in-process, release, and stability testing


Nearest Major Market: Los Angeles