Principal Cleaning Chemistry Scientist/Engineer

Role Summary

Principal Cleaning Chemistry Scientist/Engineer – Lead for site cleaning validation program, providing technical leadership in cleaning chemistry, validation, and laboratory oversight within a cGMP biopharmaceutical manufacturing facility.

Responsibilities

• Provide leadership and technical support of the site cleaning program, including cleaning chemistry, cleaning validation, and the cleaning program master plan.
• Site Cleaning Program owner and expert for cleaning validation.
• Team leader responsible for the safety and oversight of Technical Programs laboratory-based and at-scale work, including small-scale cleaning validation program requirements, mixing qualification, and solution chemical stability and expiry.
• Utilize Quality Risk Management to proactively manage risks including compliance, equipment, and systems to consistently and reliably meet cleaning program requirements.
• Provide support for manufacturing investigations related to the cleaning program.
• Collaborate and contribute to overall process improvements within a cGMP biopharmaceutical manufacturing facility.
• Member of the Andover STS Technical Programs team.

Qualifications

• Minimum: BA/BS with 6+ years of experience or MBA/MS with 5+ years of experience or PhD/JD with 1+ year of experience or MD/DVM with any years of relevant experience
• Effective written and verbal communication skills
• Strong interpersonal skills and the ability to work collaboratively across various business functions
• Experience in project management and leading complex projects
• Ability to develop and manage plans to achieve objectives

Bonus Points If You Have (Preferred Requirements)

• Master‚Äôs degree and 10+ years of relevant pharmaceutical experience
• Experience in problem-solving, negotiations, presentation, and supervision of a multi-layered organization
• Understanding of DAMIC (six sigma) tools and practices with a focus on continuous improvement
• Broad knowledge of technology transfer processes and manufacturing for Active Pharmaceutical Ingredients
• Good technical understanding of pharmaceutical processes and the impact of technical change
• Demonstrated experience and competence in organizing, planning, and problem-solving related to qualifying new API suppliers
• Strong leadership and team management skills
• Excellent analytical and strategic thinking abilities
• Ability to influence and drive alignment across stakeholders

Skills

• Cleaning chemistry
• Cleaning validation
• Laboratory oversight
• Quality Risk Management
• Process improvement
• Project management

Education

• BA/BS with relevant experience or advanced degrees as specified in qualifications

Additional Requirements

• Occasional domestic and international travel
• Occasional off-hour support to address time-sensitive production and business-related issues
• Hybrid work location