Senior GMP Project Manager – Biotech Capital Projects

Bachem Holding AG; California; In loco; USD 126.317 - 173.686; Tempo pieno

Descrizione del lavoro

The Sr. Engineering Project Manager at Bachem Americas leads the implementation of large-scale production processes and equipment, applying best-practice project management to capital projects.

You will oversee start-up activities and ensure engineers and operations staff are trained to operate new equipment. You will manage cross-functional teams across Quality, Production, Facilities, and Engineering, oversee GMP lab and equipment CapEx, and develop staff through formal training and validated

Competenze

• Advanced knowledge of GMP, cGMP and pharmaceutical manufacturing methods.
• Experience with capital projects and plant expansions.
• Strong written and oral communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience leading cross-functional project teams.
• PMP certification preferred.

Mansioni

• Lead implementation of large-scale production processes and equipment.
• Oversee system start-up activities and training of engineers and operations staff.
• Manage cross-functional teams (Quality, Production, Facilities, Engineering).
• Oversee CapEx projects for GMP laboratories and equipment and related facilities.
• Develop and train staff on maintenance schedules for new equipment.
• Support capital projects for facility remodeling and expansion.

Conoscenze

Project management

Leadership

Communication

Risk management

Budgeting

Cross-functional collaboration

GMP knowledge

Team leadership

Vendor management

Formazione

Master's degree

Bachelor's degree

Associate's degree

Descrizione del lavoro

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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 Sr. Engineering Project Manager leads the implementation of large‑scale production processes and equipment at Bachem, applying best‑practice project management methodologies to capital projects. This role oversees system start‑up activities and ensures that engineers and operations staff are fully trained to operate and troubleshoot new equipment effectively.

What you will do

• Transfer Bachem proprietary manufacturing technology from Bachem Switzerland to Bachem America.
• Leverage engineering design principles and large‑scale production technologies used in Bachem Switzerland to guide equipment implementation and ensure alignment with global standards.
• Implement and build manufacturing infrastructure to mirror Bachem Switzerland utilizing experience gained in Bachem to maximize capabilities
• Lead cross-functional teams (Quality, Production, Facilities, Engineering) within a matrix environment
• Oversee CapEx projects for new GMP laboratories and equipment (AHU, dehumidifiers, chillers, etc.), cleanrooms and lyophilizers, as well as controls and automation associated with these activities
• Develop and train employees on the utilization of maintenance schedules for new equipment
• Support the Engineering Director on capital projects for facility remodeling and expansion
• Perform activities associated with the design and qualifications of the new and existing equipment used in a manufacturing plant
• Create new process and equipment drawings based on specifications and standards
• Act as the lead project manager for the design and construction of new plant expansions and plat-related capital projects
• Work with other departments, contractors, and vendors
• Perform process development studies for new and existing projects. Write summary reports to support the process development data. Write standard operation procedures, standard test procedures, master batch records and other related GMP documents

Qualifications

• Master’s degree in engineering, science, business or related field with 5+ years of relevant work experience
• Bachelor’s degree in engineering, science, business or related field with 10+ years of relevant work experience
• Associate’s degree in engineering, science, business or related field with 15+ years of relevant work experience
• Minimum of 8 years pharm/biotech experience
• Work experience in GMP-related capital projects
• Knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles
• Technical knowledge of processes, equipment, and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.)
• Experience with peptides (preferred)
• General lab instrument (GC, FTIR, NMR and KF) knowledge and operation experience (preferred)
• PMP certification (preferred)
• Excellent written and oral communication skills
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to lead engineering teams in project management practices and assist engineering manager in developing site-wide procedures regarding managing capital projects
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Strong interpersonal skills to influence and negotiate with Bachem functional managers
• Communicate effectively and ability to function well in a team environment
• Plan projects from inception to completion.
• Ability to maintain a live-up-to-date risk register, schedule, budget and issues log related to program/project activity.

Base salary range:$126,317 - $173,686

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 Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

At Bachem, you’ll find a diverse, multicultural team. The (a)in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.