Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time -a concept that we internally adopt as "There is a Patient Waiting." Our outstanding blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more! Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters!
Discover Impactful Work:
As part of our distributed team, what you do contributes directly to our mission, enabling our customers to make the world healthier, cleaner and safer.
A day in the Life:
This position handles the oversight of Business Development, Technology Transfer, Equipment Onboarding, Launch, and Ongoing Production of Commercial products processed through primary and secondary packaging operations. This role requires attention to detail, the ability to interact with all levels of the organization, the desire to provide hands on coaching and mentoring of staff, communicating both verbally and written, and collaborating with cross- functional groups. They will also demonstrate and promote 4i Values.
Responsibilities
Demonstrates and promotes the company vision of the 4i's: Integrity, Intensity, Innovation and involvement; conducts all activities in a safe and efficient manner.
Apply company HR policies consistently throughout the area of directorial responsibility
Lead, participate, and contribute to practical process Improvement (PPI) projects that deliver business objectives in an efficient manner.
Applies Good Manufacturing Principles in all areas of responsibility and ensures that GMP's and SOP's are followed by all department employees.
Develops specific short-term and long-range goals and programs as well as supporting budget requests and financial estimates.
Recommends and defines objectives in each area of responsibility.
Coordinates client engagement/job proposals, equipment onboarding, technology transfer / validation, launch, ongoing process engineering, serialization, and packaging functions within the commercial product line.
Partners with PSG peers to implement standard processes and ensure harmonization with PSG Commercial Processes
Responsible for engaging client, crafting/defending bid proposals, and providing ongoing management of client expectations and goals.
Provides strategic direction regarding equipment needs. Assists in the selection and onboarding of commercial equipment to meet client timelines without compromise to quality.
Leads the Project Management function and client relationship associated with the technology transfer/process validation process.
Drives quality and productivity to meet client delivery requirements and financial commitments.
Participates in daily management board reviews to accurately report and communicate actions to attending departments
Assists commercial team with raised issues and resolves any issues in conjunction with QA and site leadership
Develops capital requirements to maintain and improve compliance, quality, and productivity to support the growth of the business
Develops, reviews and approves SOPs to ensure accuracy and compliance with GMP
Develops annual department objectives and strategy in alignment with site and business goals
Lead the department to make continuous improvement initiatives in areas of safety, quality, customer service, and productivity
Develops staffing resource plans to ensure that client and business needs are met
Leads the development and use of critical metrics designed to measure production efficiency
Ensures timely investigation and resolution of Quality related events
Other duties may be assigned to meet business needs
Keys to Success:
Education
Bachelor of degree, preferably science, engineering, business etc.
Experience
5+ years management level experience
5+ years of related experience in food, chemical, cosmetics or pharmaceutical packaging.
Validated experience in FDA regulated environment a plus
Validated experience owning an engineering department.a plus
Experience leading and working lean operations.
Excellent verbal and written communication skills.
Knowledge, Skills, Abilities
Previous experience in technology transfer and process engineering support a plus
Certifications for lean management, packaging, quality, supply chain, management, or pharmaceuticals are preferred
Mastery of skills required to read, understand, and guide the SOPs and policies of a GMP environment.
Can lead personnel in a cGMP environment
BENEFITS:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
