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Manufacturing Lead - Albumin 6p-6a

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
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.
The Lead Associate is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the overall direction of the supervisor, this position shall be responsible for the hands on execution of all activities in the production area. In addition to being fully accountable and involved in all production processes, he/she may problem solve in other functional areas. The incumbent acts as a delegate to the supervisor and may conduct departmental activities in their absence. He/She fully understands the regulations and may make recommendations according to their interpretations. He/She is responsible for the successful transfer of new processes/methodologies into the manufacturing area.
Essential Duties and Responsibilities
+ Must have Albumin purification experience.
+ Expected to demonstrate working competencies of MA IV.
+ Supports all local manufacturing operations.
+ Operate general production equipment
+ Prepare buffer solutions.
+ Troubleshoot process problems and respond to process alarms. Main troubleshooting/response person.
+ Assist supervisor in organizing, scheduling and directing other team members.
+ Main interface with other departments to resolve issues related to equipment, process, and compliance, including maintenance, metrology, and validation.
+ Complete relevant paperwork following GDP/GMP guidelines.
+ Write, revise and review pertinent documentation as appropriate.
+ Participate on Continuous Improvement Teams and may serve in a leadership role.
+ Represent the department in cross functional teams as necessary.
+ Initiate and/or coordinate other process improvement projects.
+ Train and mentor other team members.
+ Assist with process/equipment validation and data analysis.
+ Assign other project work and/or involvement in teams to team members.
+ Perform removal of hazardous waste
Qualifications
+ In-depth process knowledge of related manufacturing techniques and specialties.
+ Must have good written and verbal communication skills and understanding of cGMP regulations. Good procedural writing skills.
+ Must be able to read and follow detailed written instructions.
+ Must be able to apply quantitative analysis to analyze process performance.
+ 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 have demonstrated interpersonal and leadership skills and be able to work effectively and efficiently in a team environment.
+ Knowledge of basic chemical and biological safety procedures.
+ May require immunization before performing work within the manufacturing area.
+ Must have good computer skills.
Education and/or experience
Requires:
+ AA degree with 4-6 years related manufacturing experience.
OR
+ High school diploma with >8 years related manufacturing experience.
Physical Demands
_(If not applicable then edit or remove)_
+ Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
+ Must be able to stand for extended periods of time over an entire 8 or 12 hour shift.
+ Must be able to climb ladders and stairs while wearing special gowning.
+ May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
Working Environment
_(If not applicable then edit or remove)_
+ Must be able to work in controlled 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 the manufacturing environment.
+ Will work in a cold, wet environment
+ Must be able to work multiple shifts, including weekends.
+ Must be able to work overtime as required.
+ May be required to work in a confined area.
+ Some Clean Room and cool/hot storage conditions.
_Notice to Employment / Recruitment Agents:_
_Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire?s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration._
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, gender identity, 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/OFCCP_EEO_Supplement_Final_JRF_QA_508c.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.


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