Senior Associate Manufacturing

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental, and vision coverage

Discretionary annual bonus

Stock-based long-term incentives

Flexible work models

Job summary

Initial Therapeutics, Inc. is seeking a Senior Associate Manufacturing in Thousand Oaks, focusing on manual visual inspection operations and manufacturing unit oversight. This role demands strong GMP knowledge and proficiency in MES, EBR, MAXIMO, LIMS, and SAP.

Responsibilities include data analysis, scheduling, compliance auditing, and process improvement initiatives. The ideal candidate should have a Master’s or Bachelor's degree along with relevant experience in biotech/pharma manufacturing.

This position offers a comprehensive employee benefits package and flexible work models.

Qualifications

• Experience in biotech/pharma manufacturing or laboratory support.
• Proficient in GMP and able to interpret regulations.
• Experience with lab equipment and technical writing skills.

Responsibilities

• Perform manufacturing unit operations per Standard Operating Procedures.
• Schedule manufacturing operations across multiple functional areas.
• Analyze critical process parameters and propose solutions.

Skills

Manual visual inspection

Data analysis

Technical writing

GMP knowledge

Project management

Mathematical skills

Education

Master’s degree

Bachelor’s degree in biotech/pharma

Associate’s degree with relevant experience

High School Diploma with relevant experience

Tools

MES

EBR

MAXIMO

LIMS

SAP

PAS X Werum software

Job description

Senior Associate Manufacturing

Per the Manufacturing Senior Associate role within the Drug Product Supply organization in Thousand Oaks, this manufacturing support position focuses on manual visual inspection operations. Responsibilities include supervising manufacturing unit operations, scheduling across multiple functional areas, analyzing critical process parameters, operating complex equipment, implementing process improvements, ensuring compliance with milestones, reviewing and audit documentation, applying knowledge of MES, EBR, MAXIMO, LIMS, and SAP, providing process theory expertise, owning deviations/CAPA, and supporting flexible shift structure.

Job Scope and Responsibilities

• Under minimal supervision, performs manufacturing 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 equipment
• 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
• Identify and propose solutions to complex problems
• Responsible for resolving problems during operations
• Perform initial review of manufacturing procedures/batch records
• Review, revise, and audit documents
• Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP)
• Provide process theory expertise and hands‑on training to others
• Own deviations/CAPA or provide suggestions for corrective and preventative actions for deviations/safety incidents
• Apply research, information gathering, and interpretation skills to problems of diverse scope
• Utilize project management skills to set project timelines and priorities based on objectives and ongoing assignments
• Recognize and elevate problems
• Establish working relationships with others outside area of expertise
• Support flexible shift structure in support of operations (may include 24/7 or weekend)
• Understand, apply, and evaluate basic chemistry, biology, and physical principles as appropriate
• Organizational skills and 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

Basic Qualifications

• Master’s degree
• Bachelor’s degree and 6 months of experience in biotech/pharma manufacturing/laboratory or manufacturing support (laboratories, engineering, facilities, quality)
• Associate’s degree and 2 years of experience in biotech/pharma manufacturing/laboratory or manufacturing support (laboratories, engineering, facilities, quality)
• High School Diploma/GED and 4 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (laboratories, engineering, facilities, quality)

Preferred Qualifications

• Prior experience with lab equipment, computers, and intermediate mathematical skills
• Significant experience with manual visual inspection in a GMP regulated environment
• Significant 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 or related disciplines in bioprocessing (Drug Product operations)
• Demonstrated ability to work in a team

Benefits

• 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

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.