CMC Project Director (f/m/d), 100%
Bachem Holding AG, Indiana, PA, United States
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 .
To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our Global Project Management team in the Commercial area, we are looking for a dedicated CMC Project Director (f/m/d), 100%.
Leading large project teams (10-20 internal and additional external members, high technical complexity) for customer and in-house R&D projects operationally; developing CMC strategies to expand client relationships, involving strategic (shared) CAPEX opportunities with long term impact.
Acting as part of the extended Project Management Leadership Team
Acting as business lead in ongoing strategic collaborations: support contract negotiations, business proposals and forecasting, risk-sharing options
Accountable for adhering to project scope and reaching deliverables in time by considering associated agreements/contracts with the customer
Showing strong ownership for all project team deliverables
Go-to-person for project-related tasks, questions, and issues
Structuring, leading, and monitoring activities together with the project team members by using available tools and systems
Compiling accurate and fit for purpose documentation (minutes, plans, actions, summaries, strategic options, etc.) by using existing templates
Representing Bachem in project-related context towards senior and/or executive leadership of Bachem's customers, including representation in joint governance committees
Business partner to Bachem senior and executive leadership to secure necessary capacity and/or support for customer projects
Recognizing 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
Coaching more junior colleagues in the context of the technical career path; acting as mentor or dotted-line manager
Supporting the organizational development of Global PM
Your profile:
BSc/MSc/PhD or similar in a technical/scientific discipline with extensive (bio-)pharma/CDMO/chemical industry experience
MBA, PMP or similar certification of advantage
Extensive customer-facing or CMC project management experience
Advanced knowledge of general important GMP principles (e.g. ICH Guidelines) and understanding key requirements of quality systems (e.g. material qualities, setting of specifications, qualification of equipment, …)
Having 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
Experience of synthetic TIDES manufacturing and control preferred
Demonstrating professional written and verbal communication on an advanced level
Capable of working independently, reliably, and efficiently under pressure
General IT skills including MS Office/Teams and MS Project
Advanced knowledge of Bachem specific IT tools such as Salesforce, MasterControl, SAP or similar CRM, QA, or business tools
Excellent English skills, German skills of advantage
Our offer:
A dynamic and rapidly growing work environment with internal development and training opportunities
Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction
Company‑run daycare center on the Bachem Campus in Bubendorf
60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
Access to benefits platforms with discounts from external partners
Fresh, healthy and varied food in our staff restaurant
A wide range of free sports activities on the Bachem Campus
Would you like to drive innovation together with us?
We look forward to receiving your complete application documents via our application portal.
Learn more about the Bachem Group and get inspired by our exciting work environment at our location in Bubendorf!
Please note: unsolicited resumes from recruitment agencies will not be considered.
#J-18808-Ljbffr
To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our Global Project Management team in the Commercial area, we are looking for a dedicated CMC Project Director (f/m/d), 100%.
Leading large project teams (10-20 internal and additional external members, high technical complexity) for customer and in-house R&D projects operationally; developing CMC strategies to expand client relationships, involving strategic (shared) CAPEX opportunities with long term impact.
Acting as part of the extended Project Management Leadership Team
Acting as business lead in ongoing strategic collaborations: support contract negotiations, business proposals and forecasting, risk-sharing options
Accountable for adhering to project scope and reaching deliverables in time by considering associated agreements/contracts with the customer
Showing strong ownership for all project team deliverables
Go-to-person for project-related tasks, questions, and issues
Structuring, leading, and monitoring activities together with the project team members by using available tools and systems
Compiling accurate and fit for purpose documentation (minutes, plans, actions, summaries, strategic options, etc.) by using existing templates
Representing Bachem in project-related context towards senior and/or executive leadership of Bachem's customers, including representation in joint governance committees
Business partner to Bachem senior and executive leadership to secure necessary capacity and/or support for customer projects
Recognizing 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
Coaching more junior colleagues in the context of the technical career path; acting as mentor or dotted-line manager
Supporting the organizational development of Global PM
Your profile:
BSc/MSc/PhD or similar in a technical/scientific discipline with extensive (bio-)pharma/CDMO/chemical industry experience
MBA, PMP or similar certification of advantage
Extensive customer-facing or CMC project management experience
Advanced knowledge of general important GMP principles (e.g. ICH Guidelines) and understanding key requirements of quality systems (e.g. material qualities, setting of specifications, qualification of equipment, …)
Having 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
Experience of synthetic TIDES manufacturing and control preferred
Demonstrating professional written and verbal communication on an advanced level
Capable of working independently, reliably, and efficiently under pressure
General IT skills including MS Office/Teams and MS Project
Advanced knowledge of Bachem specific IT tools such as Salesforce, MasterControl, SAP or similar CRM, QA, or business tools
Excellent English skills, German skills of advantage
Our offer:
A dynamic and rapidly growing work environment with internal development and training opportunities
Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction
Company‑run daycare center on the Bachem Campus in Bubendorf
60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
Access to benefits platforms with discounts from external partners
Fresh, healthy and varied food in our staff restaurant
A wide range of free sports activities on the Bachem Campus
Would you like to drive innovation together with us?
We look forward to receiving your complete application documents via our application portal.
Learn more about the Bachem Group and get inspired by our exciting work environment at our location in Bubendorf!
Please note: unsolicited resumes from recruitment agencies will not be considered.
#J-18808-Ljbffr