Process Scientist - Global Manufacturing Science GMSci DP/PKG

Takeda • Boston, MA

97d • $153,600 - $241,340

About The Position

As a Process Scientist - Global Manufacturing Science GMSci DP/PKG, you will provide technical expertise within the GMSci DP/Pkg organizations relating to manufacturing technology and sciences for drug product manufacturing. You will serve as the SME for leading major technical transfer or validation projects relating to new product introduction or life cycle management of existing products. You will also provide leadership for regulatory interactions including CMC content for dossiers. You will ensure process knowledge is shared and leveraged across sites and functions. Serves as Takeda’s global DP SME for issue resolution as needed.

Requirements

• BS or graduate degree in Chemistry, Chemical Engineering, or other related discipline.
• 15+ years of industrial experience or equivalent.
• Minimum 10 years experience in pharmaceutical development and manufacturing.
• Previous experience in serving as a SME lead in a matrix environment relating to drug product manufacturing.
• Proficiency in dealing with ambiguity.
• Comfort with complexity and change.

Nice To Haves

• In depth and broad understanding of drug product manufacturing technologies for solid oral dosage form or injectable products.
• Knowledge of industry’s best practice and innovative/emerging technology with manufacturing of drug product.
• Ability to influence within the organization, specifically with Pharmaceutical Sciences, GMS Operating Units and CMOs.

Responsibilities

• Lead Drug Product Manufacturing Process Characterization.
• Technology Transfer to both CMOs or internal manufacturing facilities.
• Drug Product manufacturing and packaging process validation.
• Serve as experts for deployment as rapid response teams to serve all local manufacturing Operating Units.
• Manage projects within Takeda product portfolio, both development and commercial, to support Manufacturing Sciences DP and Packaging Science activities.
• Implement or provide input for strategies for the continuous improvement on the manufacturing of Marketed Products.
• Accountable for successful collaboration with other functions within GMS.
• Ensure process knowledge sharing across sites and functions for effective management of products.
• Maintain current industry leading technology knowledge, scientific approach and regulatory strategies.
• Drive and implement innovative technology at Local Technical Services organizations.

Benefits

• Medical, dental, vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• Accrual of up to 120 hours of paid vacation for new hires.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees