Sterile Manufacturing Associate at Acadia Pharmaceuticals

Sacramento, California, United States

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

High School diploma or GED required; Associate’s or Bachelor’s degree in Life Sciences or related field preferred
Experience in an aseptic or sterile pharmaceutical manufacturing environment preferred
Experience in cGMP-regulated environments is highly desirable
Strong understanding of aseptic technique, cleanroom behavior, and contamination control
Ability to read and follow SOPs, batch records, and manufacturing instructions precisely
Comfortable wearing full aseptic gowning (hoods, coveralls, gloves, booties, masks) for extended periods
Detail-oriented with strong documentation and communication skills
Ability to work independently and as part of a collaborative team
Willingness to work flexible shifts and weekends as required by production schedule
Valid driver’s license and acceptable driving record
Legally authorized to be employed in the United States

Responsibilities

Perform aseptic manufacturing operations in Grade A, B, C, and D cleanroom environments, including formulation, filtration, filling, and visual inspection
Set up, operate, and clean equipment such as vial/syringe fillers, autoclaves, and isolators under sterile conditions
Comply with all gowning requirements and environmental control procedures to maintain sterile conditions
Follow batch production records (BPRs), standard operating procedures (SOPs), and material handling protocols
Support execution of media fills, process validations, and cleanroom qualification activities
Participate in room and equipment sanitization activities, ensuring compliance with established cleaning frequencies
Complete all training in a timely manner and maintain qualification for aseptic operations
Accurately record all activities in cGMP documentation, ensuring data integrity
Assist with investigations, deviations, CAPAs, and continuous improvement initiatives
Collaborate with Quality, Validation, Engineering, and Tech Services as needed to ensure successful production runs
Follow safety, health, and environmental policies and procedures

Skills

aseptic manufacturing

cleanroom operations

cGMP

gowning

aseptic techniques

formulation

filtration

filling

SOPs

Acadia Pharmaceuticals

Develops therapies for neurological disorders

About Acadia Pharmaceuticals

Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.

Dallas, TexasHeadquarters

1993Year Founded

$813.4MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Paid Vacation

Paid Holidays

Paid Sick Leave

Paid Parental Leave

Tuition Reimbursement

Risks

Increased competition in CNS drug market may impact Acadia's market share.

Potential clinical trial delays could affect drug approval timelines.

Dependence on partnerships poses risks if collaborations face challenges or dissolve.

Differentiation

Acadia focuses on CNS disorders with unmet medical needs, like Parkinson's and Rett syndrome.

The company has a strong R&D foundation, developing innovative small molecule drugs.

Acadia's strategic partnerships enhance its research capabilities and market reach.

Upsides

Acadia's collaboration with Saniona expands its portfolio with SAN711 for neurological disorders.

Health Canada's approval of Daybue boosts Acadia's presence in the Canadian market.

The rise of personalized medicine aligns with Acadia's targeted therapy approach.

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