Manager Manufacturing (12hr PM)

Initial Therapeutics, Inc.; New Albany (OH); On-site; USD 110,000 - 165,000; Full time

Job summary

Amgen is seeking a Manager, Manufacturing- 12 Hour PM to lead a manufacturing area in an Inspection and Packaging facility and ensure production runs in full cGMP compliance. You will supervise staff, hire and develop talent, and coordinate with QA, Regulatory, and cross-functional teams to optimize processes.

The role requires strong managerial skills, experience in pharmaceutical manufacturing, and ability to work a rotating 12-hour schedule.

Qualifications

• Doctorate degree or
• Masters degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry
• Bachelors degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry.
• Associates degree and 10 years of experience in the pharmaceutical, medical device or biotechnology industry.
• High School Diploma/GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry.
• In addition, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resources

Responsibilities

• Evaluate and approve reports and protocols.
• Ensure cGMP and CFR compliance of manufacturing areas.
• Revise, update, and review procedures
• Coordinate the development and revision of SOPs.
• Evaluate current manufacturing procedures and recommend changes to management to optimize production.
• Interact with the FDA.
• Ensure Amgen policies are followed

Skills

Leadership

Team building

Verbal communication

Written communication

Conflict resolution

Analytical problem solving

Project management

Coaching

Mentoring

Change management

Regulatory knowledge

Scheduling

Presentation skills

Education

Doctorate degree

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.

Manager, Manufacturing- 12 Hour PM (6:00pm - 6:30am)

What you will do

Lets do this. Lets change the world. In this role you will be managing and leading all aspects of either a small manufacturing production area, or a section of a larger production area in an Inspection and Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed.

Specific responsibilities include but are not limited to:

• Evaluate and approve reports and protocols.

• Ensure cGMP and CFR compliance of manufacturing areas.

• Revise, update, and review procedures

• Coordinate the development and revision of SOPs.

• Evaluate current manufacturing procedures and recommend changes to management to optimize production.

• Assure all corporate change control procedures are followed, and Regulatory and QA are made aware prior to the changes.

• Interact with the FDA.

• Ensure Amgen policies are followed

Process/Equipment/Facilities:

• Ensure maintenance and re validation of systems.

• Collaborate with cross-functional teams (i.e. QA/QC, PPIC, Clinical Mfg, PD, Regulatory, etc.) in completing production activities.

• Develop, implement and assess solutions for problems.

• Responsible for resolving problems during operation.

• Coordinates set up of critical new manufacturing processes.

Staff Supervision

• Responsible for selection, training, evaluation, staff relations and development of staff.

• Ensure training programs are maintained

• Ensure scheduling of production and maintenance activities.

• Interacts with management in optimizing organizational structure and responsibilities

• Ensure plant safety through auditing and evaluations.

Administrative

• Interacts with management in planning, developing and maintaining budget.

• Assist in developing and maintaining department goals

Shift:

• This position will be supporting a rotating 12hr schedule which cycles every two weeks; 3 days one week and 4 days the next.

What we expect of you

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

Basic Qualifications:

Doctorate degree

or

Masters degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry

or

Bachelors degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry.

or

Associates degree and 10 years of experience in the pharmaceutical, medical device or biotechnology industry.

or

High School Diploma/GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry.

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Educational background in Science, Engineering or Business Administration

• Availability to work on an overnight shift

• Strong Managerial skills

• Non-Conformance and CAPA

• Ensure that all Non-conformance are triage within the established goal.

• Leadership and team building

• Verbal communication

• Written Communication including technical writing skills

• Conflict Resolution

• Analytical Problem Solving

• Project Management

• Coaching, Mentoring and Counseling

• Ability to be flexible and manage change

• Regulatory requirements

• Scheduling

• Presentation 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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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, including remote and hybrid work arrangements, where possible

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.