Upstream Manufacturing Technician

Job Summary

Responsible for providing direct oversight, coaching, mentoring and leadership in the

manufacture of biologics products performing activities within production facilities to support

manufacture of upstream/ downstream operations according to current Good Manufacturing

Practices (cGMPs).

Essential Duties and Responsibilities

- Understands, oversees, trains, coaches, mentors and manages performance of

others on basic aseptic operational techniques as well as, performing solution,

material preparation, cell culture, and purification along with analyzing results and

facility start-up engineering and mechanical knowledge

- Reviews and approves manufacturing SOPs/ protocols, executed manufacturing

documentation/ results and resolves issues

- Identifies and drives application of GMP concepts and is able to recommend and

identify improvements as the process develops during phases of technical transfer

- Identifies process and method gaps and opportunities and implements

improvements across assigned programs and site specific

- Communicates with internal and external stakeholders scientific and process data

and recommends path for forward processing

- Identifies, communicates, addresses and improves complex cGMP compliance and

regulatory gaps and issues, champions continuous improvement ideas

- Responsible for ensuring employees are trained on Batch record, SOPs,

equipment, all unit operations and non-manufacturing SOPs and systems

- Accountable for schedule execution, adjustments and performance of work

assignments for team to ensure adequate staffing across assigned activities

- Regularly interacts with and supports cross-functional teams.

- Develops, coordinates, and follows organizational systems, policies, procedures,

and follows labor and capacity standards

- May be required to work Shifts, Holidays and weekends

- Other duties as assigned

Knowledge / Skills / Abilities:

- Demonstrated Lean / Six Sigma knowledge desired

- Ability to perform arithmetic calculations including fractions, decimals and

percentages and basic algebraic and geometric calculations accurately and

reproducibly.

- Thorough understanding of Good Manufacturing Practices

- Has basic financial knowledge and acumen

- Possesses basic and fundamental engineering and mechanical knowledge and is

able to apply in the manufacturing area demonstrating unit operational and end-to-

end understanding

- Possesses technical knowledge and background in the pharmaceutical and

biotechnology industry, specifically in biologics production

- Proficient in Oral & Written communication skills

- Need to be able to read, write and understand English

- Proficient in Microsoft (Excel, Word, Outlook

Qualifications

- HS Diploma or equivalent required and BS/BA in Science related field preferred; or

combination of relevant Experience & Education

- 5+ years relevant technical experience and min 3 years in a

Lead/Leadership/Supervisory Role

Physical Requirements

- Must be able to work in an office environment with minimal noise conditions.

- Must be able to work in Lab setting with Biohazards /various Chemicals

- Must be able to wear appropriate PPE

- Must be able to work in environment with variable noise levels

- Ability to stand /Sit/walk for long periods of time

- Ability to Lift/ push pull 50 lbs routinely

- Ability to crouch, bend, twist, and reach

- Clarity of Vision and have the ability to identify and distinguish colors

- Must be able to perform activities with repetitive motions

Ability to climb Ladders / Stairs / Scaffolding

- Ability to work in variable temperatures high to freezing

- Inside/outside working conditions