Shire Supervisor I, Manufacturing (F in Thousand Oaks, California

Essential Duties & Responsibilities

  • Supervise the day to day production, scheduling, staffing, material management, compliance, training, and auditing activities for area of responsibility.

  • Supervisor on the floor 75% of the time

  • Develop and manage performance of direct reports.

  • Support and ensure execution of all manufacturing processes with strict compliance to cGMPs and EHS regulations.

  • Perform or support technical reviews, investigation and process improvement projects.

  • Provide input into integration and validation of new equipment and process.

  • Resolve technical, material, and cGMP issues.

  • Review, approve, and manage documentation for batch and system records for production.

  • Interface with other departments to help resolve issues related to equipment, process and compliance including facility support departments and external vendors.

  • Lead/participate in technical reviews, investigation and process improvement projects in order to meet objectives

  • Assess impact of new regulatory guidelines on current practice, initiate document change proposals, prepare/review protocols to justify process changes, assist with training and auditing as appropriate.

  • Owner for implementation of new equipment, system and/or procedures.

  • Participate in Internal or external audits as SME for department.

  • May perform other duties as assigned.

Qualifications

The individual should be able to identify errors or faults in process and recommend or implement solutions.

  • Basic supervisory and leadership skills.

  • Able to manage multiple priorities in manufacturing plant setting.

  • Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.

  • Knowledge of Cell Culture, Purification, and Buffer/Media manufacturing operations.

  • Understands Manufacturing Production Process for all functional areas. Expertise grows in depth and breadth as individual moves up the career ladder.

  • Knowledge of Utility Systems and how they impact the Manufacturing Departments.

  • Understands the flow and design/interdependency of manufacturing support departments.

  • Knowledge of manufacturing equipment operation, including set up and changeover, as well as commissioning, validation, and troubleshooting.

  • Basic scientific understanding of biology (cell culture, microbiology) and chemistry/ biochemistry as it applies to the manufacturing process.

  • May have more specific skill sets in areas depending on need/ opportunity: Aseptic technique, column packing, inoculum operations, chromatography operations, etc.

  • Knowledge of clean room management.

  • Basic professional writing skills and ability to prepare and write technical reports

  • Basic verbal and written communication skills across multiple functional areas.

  • Computer skills, including PowerPoint, Word, Excel, Access.

  • Knowledge of basic chemical and biological safety procedures.

  • Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.

  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.

  • Must be able to read, write, and converse in English.

  • Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.

  • Must have the ability to navigate electronic mail systems and intranet for communication purposes.

  • Advanced word processing skills.

  • Advanced spreadsheet skills.

  • Advanced typing skills.

  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.

Education and/or Experience

Bachelor’s Degree plus 1-3 years of manufacturing experience, or AA Degree with 3-6 years of manufacturing experience, or HS Diploma with 5-8 years of manufacturing experience. Minimum of 0-2 years of leadership experience. Scientific or engineering degree preferred.

Working Environment

  • Must be able to work in controlled or clean room environments requiring special gowning.

  • Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.

  • May work in a cold, wet environment.

  • May be exposed to dust, gases, and fumes.

  • May be around and operating moving equipment and machinery.

  • May climb up and into large processing tanks for cleaning or inspection.

  • May be working in a loud area that requires hearing protection and other protective equipment to be worn.

  • May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.

  • May be required to work in a confined area as defined by the Environmental, Health, & Safety office.

  • Possible exposure to cool/hot storage conditions.

  • Will have interaction with other people.

  • Pace may be fast and job completion demands may be high.

  • May be required to travel for business reasons, e.g. training and meetings .

  • May be required to work or be assigned to a different shift as needed.

  • Must be able to work more than 8 hours a day or 40 hours a workweek as required.

  • This position requires shift, weekend and holiday work.

  • Maybe required to work 4 days a week 10 hour days.

Physical Demand

The overall physical exertion of this position requires medium to heavy work.

  • May be required to sit between 1-2 hours in the Manufacturing areas.

  • May be required to walk between 1-2 hours in in the Manufacturing areas.

  • May be required to stand between 1-2 hours in in the Manufacturing areas.

  • May be required to bend at the neck for up to 1 hour in the Manufacturing areas.

  • May be required to bend at the waist for up to 1 hour in in the Manufacturing areas.

  • May be required to squat up to 1 hour in the Manufacturing areas.

  • May be required to climb (use step stools and ladders) up to 1 hour in all Manufacturing areas.

  • May be required to reach above/below the shoulder) up to 1 hour in all Manufacturing areas.

  • May be required to kneel up to 1 hour in all Manufacturing areas.

  • May be required to twist at the neck/waist up to 1 hour) in all Manufacturing areas.

  • May be required to lift up to 10lbs in all Manufacturing areas. Lifts per shift up to 2 times in all Manufacturing areas.

  • May be required to carry up to 10lbs in in all Manufacturing areas. Carry distance of up to 20ft in all Manufacturing areas. Carries per shift up to 2 times in all Manufacturing areas.

  • Requires repetitive use of both right and left hands and arms for over 4 hours in all Manufacturing areas.

  • May require simple grasping between 3-4 hours in in all Manufacturing areas.

  • Does not require power grasping.

  • Does not require fine manipulation.

  • May require pushing/pulling with hands/arms of up to 1 hour in all Manufacturing areas.

  • May require office work activities with hands/arms over 4 hours in all Manufacturing areas..

  • May be required to gown frequently and balance when gowning into clean areas.

  • Not required to drive a car, truck, forklift and other equipment.

  • May be required to work around moving equipment and machinery in all Manufacturing areas. Machinery includes bioreactors and associated pumps and controllers.

  • May require walking on uneven ground.

  • Does not require exposure to noise above 85 dBA.

  • Does not require exposure to hot, cold, wet environment/conditions.

  • May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes in all Manufacturing areas.

  • May require respiratory protection. May be exposed to IPA, bleach and cleaning chemicals.

  • Does not require work at heights above floor level.

  • Does not require operation of foot controls or repetitive foot movement.

  • Does not require the use of special visual or auditory protective equipment.

  • Does not require working with biohazards such as: bloodborne pathogens, sewage or medical waste.

  • May be required to drive to travel to other facilities, training sites, and off site meetings.

  • May be required to work in confined areas.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.