Specialist - Manufacturing - Engineering Support

Initial Therapeutics, Inc.; New Albany (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement plan with company match

Stock-based long-term incentives

Discretionary annual bonus program

Flexible work models where possible

Job summary

Amgen seeks a qualified professional to support the manufacturing team by drafting and revising SOPs, WI, and technical reports in a GMP environment. This role leads quality records such as deviations, CAPAs, and change controls with SME input.

You will collaborate across departments to improve documentation, training materials, and process improvements while ensuring timely, accurate records.

Qualifications

• Doctorate degree required in a relevant field.
• Masters degree with 2 years in Engineering, Manufacturing, Packaging or Quality in pharmaceutical/biotech sectors.
• Bachelor's degree with 4 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech.
• Associate's degree with 8 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech.
• High school diploma / GED with 10 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech.

Responsibilities

• Develop, review, and update technical content including SOPs, WIs, risk assessments, protocols and reports for manufacturing.
• Generate, own, and provide SME to Quality System records such as deviations, CAPA and change control records.
• Provide technical and clerical support to the manufacturing team in documenting, data collation and tracking.
• Liaise with manufacturing and cross-functional departments on documentation changes.
• Collaborate with multiple departments to support training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and troubleshooting projects.
• Assist in reducing document turnaround times for the manufacturing team.
• Ensure actions are completed on schedule and documents are current.
• Develop protocols for execution in Manufacturing to support change controls and investigations.
• Track pending activities required to support change control implementations.
• Liaise with Quality Assurance to maintain GMP standards.
• Share knowledge with manufacturing team members.

Education

Doctorate degree

Master's degree with 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Bachelor's degree with 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Associate's degree with 8 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

High school diploma / GED with 10 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Lets do this. Lets change the world! In this role you will support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOP'S), Work Instructions (WI), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.

This role will also lead and own quality records such as deviations, CAPAs, Change Controls, and Quality Risk Management and provide expertise in Amgens Quality Management System (QMS).

Responsibilities may include, but are not limited to:

• Develop, review, and update technical content including but not limited to SOPs, WIs, risk assessments, protocols & reports for manufacturing team.
• Generate, own, and provide subject matter expertise to Quality System records as minor/major deviations, CAPA and change control records.
• Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data and tracking of technical documents.
• Liaise with manufacturing team and other cross functional departments regarding documentation changes in an effective and timely manner.
• Collaborate with multiple departments to support new/revise training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and / or troubleshooting projects.
• Support manufacturing team in reducing document turnaround times.
• Ensure documentation related actions are completed on time and current schedule is maintained, accurate, and up to date.
• Develop protocols for execution in Manufacturing to support change controls, deviations & troubleshooting investigations with provision from relevant SMEs.
• Track pending activities required to support change control implementations.
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems.
• Share knowledge with members of the manufacturing team.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree

Or

Masters degree and 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

Bachelors degree and 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

Associates degree and 8 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

High school diploma / GED and 10 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Preferred Qualifications:

• Educational Background in Science and/or Engineering.
• Experience working in GMP pharma and/or biotechnology industry.
• Experience in a Good Manufacturing Practices (GMP) environment and solid background in technical writing.
• Experience with device assembly and packaging of final product.
• Ability to translate highly technical information into easily understandable information for manufacturing operators.
• Creative skills and usage of photographs, drawings, diagrams, animation, and charts that increase users understanding.
• Experience supporting deviations, investigations, CAPAs and change controls.
• A fact-based problem solver with strong troubleshooting and problem-solving skills.
• Pro-active, result driven, and ability to prioritize work to meet deadlines.
• Good documentation and communication skills.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.