14 days old

Manufacturing Associate II (Downstream) - San Diego

Kelly Services
San Diego, CA 92108
**Title:** Manufacturing Associate II (Downstream)

**Location:** San Diego, CA

**Position Type:** Contract to Hire

**Shift:** 12 hour rotating shift

Monday Wednesday 7:30am-7:30pm (3 days, every other week)

Monday Thursday 7:30am-7:30pm (4 days, every other week)

**Hourly Pay: Depending on Experience**

**Overtime:** Overtime paid after 8 hours (4 hours overtime every day)

**Position Responsibilities:**

+ Expects to work in a cGMP manufacturing environment.

+ Responsible for specific product-related operations in protein purification.

+ Trains all manufacturing staff. Ensures that all operators are trained on an activity prior to GMP execution.

+ Operates and maintains production equipment with single-use materials as it relates to harvest and protein purification (chromatography columns, depth filtration, cassette and hollow fiber-based ultrafiltration equipment, UV monitors, pH/conductivity, viral filtration, AKTA skids).

+ Expected to adjust to a flexible work schedule.

+ Obtains and stock supplies as directed.

+ Organizes and executes manufacturing in production-scale protein manufacturing.

+ Conduct activities in support of production schedules as directed by senior staff.

+ Performs a variety of complex tasks in accordance with cGMP, cGDP, SOPs and Batch Records.

+ Initiates deviations assist in assessing product quality impact and assisting with proposals for Corrective and Preventative Actions (CAPA).

+ Reviews SOPs, Master Batch Records, Specifications and other applicable cGMP documentation for Manufacturing.

+ Prepares technical reports, batch summaries, protocols, batch records, specifications and quantitative analyses.

+ Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.

+ Reviews completed Production, Buffer and Purification batch records daily for cGMP compliance and completeness.

+ Supports and directs floor operations for multiple projects simultaneously.

+ Monitor processes and results and suggest methods to ensure process success.

+ May cross-train on various tasks including Upstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group.

+ Develops effective working relationships with internal partners.

+ Represents departmental activities as needed, including project teams.

+ Provides feedback to Senior Management.

+ Performs other duties as assigned.

**General Responsibilities:**

+ Operates to the highest ethical and moral standards.

+ Complies with policies and procedures.

+ Inventory manufacturing lab supplies and ensure items are properly stocked

+ Maintains records to comply with regulatory requirements and assist with in-process testing.

+ Adheres to quality standards set by regulations and policies, procedures and mission.

+ Communicates effectively with supervisors and colleagues.

+ Ability to participate effectively as a team player in all aspects of business.

+ Travels as needed between GMP facilities.

**Qualifications/Skills Required:**

+ BA/BS degree that included laboratory work in a chemistry, biology or related field.

+ At least 3 to 4 years of experience in a GMP pharmaceutical or biotech environment.

+ Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities

+ Skilled with using single-use technologies and disposable systems

+ Ability to follow detailed instructions and to maintain accurate records.

+ Ability to work effectively in a team environment.

+ Effectively communicate status of floor operations to leads and senior staff

+ Able to efficiently track and operate multiple projects and multitask when required.

+ Some experience with troubleshooting downstream operations preferred.

+ Ability to safely operate production equipment in accordance with established practices.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-11-11 Expires: 2020-12-12

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Manufacturing Associate II (Downstream) - San Diego

Kelly Services
San Diego, CA 92108

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