Senior Associate Laboratory Support (JP7742)
Thousand Oaks, CA. (Onsite Essential)
Drug Product, Supply, and Manufacturing
7a-4p, must be flexible due to production demand, some weekends required
1+ years (with likely extensions)
3 Key Consulting is hiring an Senior Associate Scientist
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
- Must have 2+ years of Pharma or Biotech manufacturing/laboratory or manufacturing support.
- Analytical testing experience.
This is a manufacturing support role responsible for manual visual inspection and testing in manufacturing operations teams. This Senior Associate position will be focused on:
- Characterization, sample, data, and equipment management.
- Process improvement projects/assignments within operations.
- Quality systems (Deviations/CAPA/CAPA EV/LIMS/MES/SAP/MAXIMO) support.
- Support new product introduction activities.
- Support production.
- Maintain open communication between operations teams.
- This Senior Associate position will be focused on manual visual inspection and testing in manufacturing operations.
Job Scope and Responsibilities:
Why is the Position Open?
- Under minimal supervision, performs manufacturing and laboratory unit operations according to Standard Operating Procedures.
- May schedule operations for multiple functional areas.
- Understand process parameters and can identify process anomalies.
- Perform data analysis of critical process parameters.
- Operate complex critical processing equipmen.t
- Assist, plan and implement continuous improvement solutions related to routine functions.
- Assist in ensuring operations are completed per manufacturing schedule which may include delegation of tasks.
- Primary resource related to processing operations on the mfg floor/laboratory.
- Identify and propose solutions to complex problems.
- Responsible for resolving problems during operations.
- Perform initial review of manufacturing/laboratory procedures/batch records.
- Review, revise, and audit documents.
- Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge).
- May own deviations/CAPA or provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents.
- Applies research, information gathering, analytical and interpretation skills to problems of diverse scope.
- Utilizes basic project management skills to set project timelines and priorities based project objectives and ongoing assignments.
- Recognizes and escalates problems.
- Able to establish working relationships with others outside area of expertise.
- Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend).
- Ability to understand, apply, and evaluate basic chemistry, biology, and physical principals as appropriate for the position.
- Organizational skills and an ability to perform assignments with a high degree of attention to detail.
- Written and oral communication skills. Technical writing capability.
- GMP knowledge with ability to interpret and apply applicable regulations.
- Ability to understand analytical methods for manufacturing/laboratory area.
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- Manufacturing GMP experience in biotech field.
- Analytical testing experience, preferably in QC.
- Flexible schedule based off production demand.
- Manual visual inspection of filled units.
- Analytical testing for product release.
- Bachelor’s degree and 2 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
- Associate’s degree and 5 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
- High School Diploma/GED and 8 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
- Prior experience with lab equipment, computers, and intermediate mathematical skills
Employee Value Proposition:
- Experience with manual visual inspection and/or laboratory in a GMP regulated environment.
- Experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
- Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology
- Demonstrated technical writing skills
- Strong knowledge of manual visual inspection and laboratory background or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
- Demonstrated ability to work in a team
Experience within a manufacturing setting & exposure to leadership/ departments.
- No GMP experience.
- No analytical laboratory experience.
- Unable to support dynamic production schedule.
Video Skype Panel Interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.