Job Description
When you are part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clients across the world. Whether planning, packaging, labeling, storing, or distributing important supplies, Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. http://www.fisherclinicalservices.com/
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 embrace as "There is a Patient Waiting." Our unique 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.
How will you make an impact?
As part of our global team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer.
What will you do?
Our company seeks a Director, Packaging and Manufacturing responsible for the daily oversight of clinical products processed through primary and secondary packaging operations. This role requires attention to details, the ability to interact with all levels of the organization, the desire to provide hands on coaching and mentoring of staff, ability to communicate both verbally and written, and collaborate with cross-functional groups. They will also demonstrate and promote the company vision of the 4 I's.
How will you get here?
Bachelor of Arts / Bachelor of Science and 10+ years of related experience in food, chemical, cosmetics or pharmaceutical packaging.Applies Good Manufacturing Principles in all areas of responsibility.Demonstrates and promotes the company visionRecommends and defines objectives in each area of responsibility. Develops specific short-term and long-range goals and programs as well as supporting budget requests and financial estimates.Manage all activities and all projects in conjunction with local change control procedures.Apply company HR policies consistently throughout the area of directorial responsibilityLead, participate, and contribute to practical process Improvement (PPI) projects that deliver business objectives in a cost-effective manner.Demonstrates and promotes the company vision of the 4 I's: Integrity, Intensity, Innovation and involvement; conducts all activities in a safe and efficient manner.Oversee the packaging, manufacturing, process engineering, and operational excellence functions.Responsible for assuring that GMP and SOP guidelines are followed by all packaging and manufacturing employeesOversees the output and quality of the department on all shiftsApplies Good Manufacturing Principles in all areas of responsibility, and ensures compliance for all functional areasConducts all activities in a safe manner, and ensures compliance with all site, company, and government procedures, policies, and regulations for all operations staff.Drives quality and productivity to meet client delivery requirements and financial commitments. Participates in daily management board reviews and Gemba walks to accurately report and communicate actions to attending departmentsAssists area managers with escalated issues and resolves any issues in conjunction with QA and Team LeadersWorks with Project Management to resolve any questions associated with manufacturing and packaging operationsParticipates and successfully completes required training sessions for standard operating procedures, quality, safety, etc.Develops capital requirements to maintain and improve compliance, quality, and productivity to support the growth of the businessProvides Feedback to Senior Management with any issues and concerns, and provide monthly reports on quality, safety, on-time performance, and productivity of the groupReviews and approves SOPs to ensure accuracy and compliance with GMPDevelops annual department objectives and strategy in alignment with site and business goalDevelops annual goal for direct reports and evaluate performanceLead the department to make continuous improvement initiatives in areas of safety, quality, customer service, and productivityDevelops staffing resource plans to ensure that client and business needs are metReview weekly backlog and communicate results to the Director of Finance to help forecast monthly financial reviewsReviews and approve change controls, ensuring associated risks are defined and action plans are acceptableOversees the development and use of critical metrics designed to measure production efficiencyDetermines engineering requirements for upcoming projectsInvestigates cause of excessive reject rates and equipment set up cycles and apply corrective actionsEnsures timely investigation and resolution of Quality related eventsOther duties may be assigned to meet business needs
Knowledge, Skills, Abilities
Ten years of progressive experienceExperience leading and working lean operations.Excellent verbal and written communication skills.5 years of experience in FDA regulated environmentPhysical considerations: May be required to lift 10-20 pounds. Long periods of standing to monitor room activities and assist in production as needed. Allergies to specific pharmaceuticals may disqualify individuals from performing these duties.10 years of experience in FDA regulated environment preferredCertifications for lean management, packaging, quality, supply chain, management, or pharmaceuticals helpfulMastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.Can manage personnel in a cGMP environment
Physical Requirements
The position is administrative, is positioned in an office environment and requires standing, bending, reaching, walking, and talking as well as exerting up to 20lbs of force occasionally.
Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.