CMC Project Leader at Bachem Americas, Inc.

Posted in Other 3 days ago.

Location: Vista, California





Job Description:

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status


Bachem Americas, Inc.


Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.



A brief overview

The CMC Project Leader will lead a complex customer-related portfolio of projects including business activities with the accountabilities to achieve project goals, create value, and foster a successful collaboration between Bachem and the customer.

What you will do

  • Lead large project teams (10-20 internal and additional external members, high technical complexity) for customer and in-house R&D projects operationally; develop CMC strategies to expand client relationships involving strategic (shared) Capex opportunities with long-term impact.
  • Serve as business partner to Bachem senior and executive leadership to secure necessary capacity and/or support for customer projects
  • Act as business lead in ongoing strategic collaborations: contract negotiations, business proposals and forecasting, risk-sharing options. Reporting accurate project data in existing tools for Customer Relationship Management (CRM) and Document Exchange Platforms (e.g. Salesforce, Teams)
  • Represent Bachem in project-related context towards senior and/or executive leadership of Bachem's customers, including representation in joint governance committees
  • Recognize opportunities within project operations to expand scope of the existing collaboration, and proactively taking those up with the project team for presentation to the customer with the target of generating significant additional business
  • Coach colleagues in the context of the technical career path; acting as mentor
  • Structure, lead and monitor activities together with the project team members by using available tools and systems
  • Accountable for adhering to project scope and reaching deliverables in time by considering associated agreements/contracts with the customer
  • Go-to-person for project-related tasks, questions, and issues (in line with roles and responsibilities as defined in the PM guide)
  • Report accurate project data in existing tools for Customer Relations
  • Drive organizational development of Global PM (e.g. Project Management Transformation)
  • Show strong ownership for all project team deliverables
  • Compiling accurate and fit for purpose documentation (minutes, plans, actions, summaries, strategic options, etc.) by using existing templates
  • Act as advisor to Senior Leadership in support of developing growth opportunities with current and new customers

Qualifications

  • Master's degree in science (Chemistry, Biochemistry, Biology, Bioengineering or similar field, with 10 years of CDMO/Chemical/Bio-Pharma industry experience or
  • PhD In Science (Chemistry, Biochemistry, Biology, Bioengineering or similar field, with 5 years of CDMO/Chemical/Bio-Pharma industry experience or
  • Bachelor's degree in science (Chemistry, Biochemistry, Biology, Bioengineering or similar field, with 15 years of CDMO/Chemical/Bio-Pharma industry experience
  • MBA (preferred)
  • PMP Certification (preferred)
  • 10 years of customer-facing or CMC project management experience
  • Experience of synthetic TIDES manufacturing and control (preferred)
  • Extensive experience with different types of customers (small/biotech and large)
  • Advanced knowledge of general important GMP principles (e.g. ICH Guidelines) and understanding key requirements of quality system (e.g. material qualities, setting of specifications, qualification of equipment)
  • Extensive knowledge of clinical development (phases, key goals, requirements) and associated regulatory compliance/filings for drug substances
  • Proven track record of independently managed CMC projects, e.g. from preclinical, clinical to commercial
  • Ability to utilize MS Office/Teams and MS Project
  • Advanced knowledge of software systems such as Salesforce, Master Control, SAP
  • Capable of working independently, reliably, and efficiently
  • Demonstrating professional written and verbal communication on an advanced level

Base Salary Range: $142,640 - $178,300

Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees' environmental awareness.EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.

           

Bachem Americas is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status







PI243197014


More jobs in Vista, California


Walmart

Walmart

Walmart
More jobs in Other


Wellstar Health Systems

Wellstar Health Systems

Wellstar Health Systems