CH = Contract to Hire

C = Contract

DP = Direct Placement

DOE = Depending on experience

GTW = Go To Work (no interview)

HOTTEST OPENINGS ARE HIGHLIGHTED

Research Associate, Downstream x3 – CH – UTC

$17-30/hr DOE

From the hiring manager:

“I have been asked to begin recruiting 3 Research Associate Positions for my Downstream PD Team. I am looking for candidates that satisfy all (or some) of the following criteria:

Junior and/or entry level in general, although not necessary, if other qualifications line up and the candidate is willing to discuss the situation.
The position will involve projects dedicated to developing purification protocols that yield an antibody product that meets our specifications of purity and stability.
General science education (BS is fine) and/or some degree of experience in the lab
Specific areas of knowledge and/or experience that would be regarded as a plus:
Protein purification: column chromatography principles and techniques, familiarity with AKTA systems and Unicorn software
Buffer preparation
Centrifugation and filtration
General understanding of protein biochemistry

“I would rather see more than less of the available resumes to get a feel for the breadth of available talent. The most important attributes I will be looking for is enthusiasm and trainability, and how those lines up with their education and experience.”

Project Coordinator – CH – UTC

$17-25/hr
Bachelor's Degree in the biology or chemistry is preferred. Minimum of 3-4 years of college coursework in the sciences, or equivalent work experience is required.
Aseptic manufacturing experience is strongly preferred.
Good documentation, strong organizational and record keeping skills are essential.
Excellent verbal and written communication skills are required.
Must be a team player, customer service oriented, willing to learn, and able to work flexible hours.
The Project Coordinator is responsible for coordinating and running processes associated with the manufacture of the customer's product in manufacturing. This includes working with Project Managers in communication with the customer, ensuring inventory is available to begin the process, and coordinating the scheduling of the job including the needs of personnel, equipment and space. The Project Coordinator is directly involved in the set-up, formulation and aseptic filling and lyophilization of buffers and solutions, and the timely completion of all associated documentation throughout the entire process. They are to ensure that personnel follow all regulations and written procedures applicable to the job. Project Coordinators will also write procedures, perform validations, and investigate failures as necessary. The ideal candidate should be able to work with minimal instructions, and should be able to provide some direction to area technicians

Director, Upstream – DP – UTC

$DOE
BS/MS or PhD with 5 years+ upstream processing, prefer prior director- would probably look at associate director
DEPARTMENT: MANUFACTURING/OPERATIONS
As a member of the senior management team, this individual will be involved in the production and processing of recombinant proteins for clinical use.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manage a complex workload for cell line development, upstream process development, and upstream manufacturing activities.
Responsible for leading a team of supervisors and technicians.
Provide support to cross-functional teams to meet production or timeline demands.
Demonstrate understanding and provide oversight on technical operations, safety, and Good Manufacturing Practice.
Provide oversight on upstream processes as well as cleanroom facility and equipment operations.
Develop staff capabilities, creating a culture of safety, maintain training objectives, compliance and collaboration while implementing process improvements where applicable
Initiate, review, and revise cGMP Batch Production Records, SOP’s, Process Development reports, and Manufacturing Summary reports.
Ensure the completeness and accuracy of manufacturing documentation per approved procedures.
JOB REQUIREMENTS:
Expert in cell line development, upstream process development and upstream manufacturing processes
PhD’s degree in Life Sciences or Chemical Engineering with more than 7 years of relevant experience in GMP production including aseptic processing or a BS / MS degree in Life Sciences or Chemical Engineering with more than 15 years of relevant experience.
Practical Experience with cGMP operations.
More than 5 years of supervisory experience
Must be proficient in Word and Excel.

Doc Control Specialist - CH - UTC

$20/hr.+
We need a Document Control Assistant who has a strong quality background and mindset who will be an advocate for the Quality system changes we are making (in other words, able to accept changes and able to think creatively to help with change. This individual will also need:
A minimum of two years of Quality Assurance experience, preferably within a cGMP environment within the Pharmaceutical / Biotech Industry.
Experience with Batch record and document review
Experience with area / line clearance
Experience with performing and writing investigations

Quality Operations Associate – C/CH – Torrey Pines

$20-24/hr

70% on Document Control/Review (for next 2 months), 30% on QA role (product batch review, QA release, daily kit verifications)
ALL manual documentation
The role’s process: Obtain the document à Doc Control, Doc Change Process à formatting, editing, bounce back à get approval signatures à put into document mold
MUST be a good communicator = Will be interfacing with reagent manufacturing, product managers, quality consultants, regulatory head
Will have weekly 1 on 1 with the hiring manager to touch base/check in since this is a BRAND NEW ROLE
MUST HAVES: good with Excel AND word, computer savvy, 3+ years of experience in this field, self-motivated, attention to detail, ability to multi-task

Preferred experience:

College courses and experience in the appropriate scientific and quality disciplines.
Three or more years of relevant industry experience in a Manufacturing Quality role.
Proficient with office equipment, computer systems and other tools of the administration function assigned.
Proficient in using MS Office, WORD, Excel and other data systems is required
Excellent written and verbal communication skills
Must be detail-oriented with strong prioritization and organization skills
Able to handle multiple tasks and work in a fast paced environment

Responsibilities:

Assist with document authoring and editing under the document change control system including creation and revision of SOPs to support quality processes. This responsibility requires formatting and routing the document including obtaining the appropriate approvals throughout the process.
Review of production documents including manufacturing/production batch records.
Generate Certificate of Analysis (CoA) for products.
Perform transactions such as Incoming Material Inspection.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies & practices.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR a plus.

Manufacturing Associate II AND III – DP – Sorrento Valley

$45-55k for level II, $55-65k for level III
The Manufacturing Associate III will assist with all aspects of production, including the production of master mixes, controls, and assay kits.
This position will manufacture products adhering to existing Quality System Regulations that are accompanied by appropriate documentation.
The Manufacturing Associate III will review, edit, create, and maintain documents, including Standard Operating Procedures, Batch Records, and Purchasing Specifications.
Some administrative work may be required (maintaining inventory, and other duties as necessary).
Requires knowledge and skills normally acquired through the successful completion of a BS Degree in a scientific discipline.
Requires 2+ years of experience in a GMP regulated industry or equivalent combination of education and experience.

SKILLS / KNOWLEDGE / ABILITIES

Direct working knowledge of a production environment, including use of SOPs, batch records, ERP systems and purchasing specifications.
Ability to recognize deviation from accepted practice is required.
Strong working knowledge of PCR and molecular biology.
Experience with sterile techniques and accurate pipetting skills.
Meticulous and detailed oriented.
Ability to follow Standardized Operating Procedures (SOPs) as well as written and verbal instructions.
Ability to work independently as well as in a team environment.
Excellent written and verbal communication skills with the ability to train employees.
Ability to manage multiple projects and changing priorities.
Willingness to learn and take on new challenges. Able to use Adobe Acrobat, Illustrator, and Photoshop for art work and graphics in documents.

Development Associate I, II, III – DP – Torrey Pines

Pays $40-65k DOE
Molecular Biologist with industry experience
Will be doing development, supporting manufacturing

Supports manufacturing technical support projects that can include generating analytical data for an FDA submission.
Performs the design, execution and documentation of moderately complex experiments that support existing reagents and assays. Experimental design will include all of the appropriate controls.
Independently writes study protocols and reports that may be auditable.
Maintains a laboratory notebook that records all aspects of experimental design and results, following good documentation practices. When applicable, maintains electronic copies of experiments, procedures, instructions, data and analysis in appropriate locations.
Uses laboratory techniques such as preparation of buffers and media, aseptic technique, cell culture, specimen processing, PCR, gel and capillary electrophoresis and sequencing.
Independently operates laboratory equipment such as thermocyclers, spectrophotometers, fluorometers, centrifuges, cell counters, autoclaves, scales, capillary electrophoresis instrumentation, sequencers, real-time PCR platforms and DNA isolation workstations.
Performs data analysis using available software such as Microsoft Excel, JMP and GeneMapper.
Cooperates and respectfully communicates with external customers and internal customers.
Other duties, as assigned.
3+ years of experience in R&D (not just research), development and/or manufacturing
Supports manufacturing technical support projects that can include generating analytical data for an FDA submission.
Performs the design, execution and documentation of moderately complex experiments that support existing reagents and assays. Experimental design will include all of the appropriate controls.
Independently writes study protocols and reports that may be auditable.
Maintains a laboratory notebook that records all aspects of experimental design and results, following good documentation practices. When applicable, maintains electronic copies of experiments, procedures, instructions, data and analysis in appropriate locations.

Labeler – C – Sorrento Valley

$13/hr
AS or BS, labelling experience is ideal
Must be good with attention to detail
Requires knowledge and skills normally acquired through the successful completion of a BS Degree in a scientific discipline. Prefers accessioning exp.
data entry, accessioning

QC Analyst II x2 – C/CH – Torrey Pines

$16-25/hr DOE
The purpose of the QC Analyst II is to carry out assigned laboratory duties which may include sampling, testing, and evaluating analytical data on samples such as raw materials, in-process and final products. In addition, will also participate in the development and validation of analytical methods.
2 years of relevant hands-on laboratory experience.
BS degree in scientific discipline from an accredited college or university or equivalent experience.
Demonstrated computer proficiency, e.g., word processing, spreadsheets, graphing, etc
Good knowledge of cGMPs and laboratory practices.
Proficient in the operation and maintenance of basic laboratory instruments such as HPLC and GC.
Excellent observation skills and problem solving abilities.
Ability to follow analytical procedures and protocols.
Good laboratory techniques.
Conduct laboratory tests in compliance with established internal Standard Test Methods, compendial and vendor/partner supplied methods.
Maintain organized records of tests performed and results obtained following company policies
Assist in performing laboratory investigations. Write investigation report as required.
Maintain a level of technical knowledge and understanding in the assigned areas of responsibility that are consistent with the current scientific requirements of the company.
Understand and comply with all company policies, safety procedures, and SOPs, including cGMPs and cGLPs
Assist in the preparation of analytical data for internal and external meetings and presentations.
Provide technical assistance and training to other laboratory personnel.
Participate in the transfer of methods to/from the Quality Control department.
Represent functional area in Project Teams, as required.
Write documents for GMP compliance such as standard test methods, validation reports, and SOPs.

Manufacturing Technician – CH – Sorrento Valley

$15-25/hr DOE
Bachelor’s Degree in Biochemistry, Biology, Chemistry, or a related field
1-5 years of experience in antibody purification or protein purification
Solid understanding of antibody structure and hands-on experience with chromatography
Good computer skills
Follow SOP’s
Perform all essential functions related to antibody purification manufacturing, including centrifugation, making buffers, using the spectrophotometer, running SDS-PAGE gels, and performing endotoxin tests
Perform basic math calculations to determine the concentration and amount of antibodies
Perform column chromatography manually as well as using FPLC
Use of ERP database to execute production orders
Maintenance of laboratory equipment and supplies

Manufacturing, Data Entry Clerk – C – Sorrento Valley

$14/hr
Job Description: The Manufacturing Data Entry Clerk will work closely with all of the Manufacturing teams to understand and streamline Manufacturing production processes. The person in this position will be responsible for finishing production orders, creating labels for QC samples and bulks made by Manufacturing teams, working closely with inventory controllers to create Bin locations for purified and conjugated bulks and maintaining their accuracy, and reviewing, verifying, and scanning/attaching batch records into ERP system. This position will also be responsible for helping the Inventory and Planning teams to resubmit re-test samples and will perform other duties as necessary.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Helping to finish production orders and creating labels for QC samples and bulk materials
Assisting with batch records (reviewing/verification and scanning/attaching)
Helping the inventory controller to identify Bin locations and helping Planning teams to resubmit re-test samples
Performing job duties under ISO requirements such as following " line of clearance" rule and following SOP's or work instructions
Other duties as assigned
Work Environment: work at computer in protein production lab
Qualifications: BS Degree. open to non-degree with experience
Perform antibody conjugation and purification
Follow SOPs to perform experiments. Use ERP database and other database to document activities.
Set up production specification for manufacturing
Trouble-shooting problematic conjugations with emphasis on optimizing reaction condition

Recombinant Antibody Manager – DP – Sorrento Valley

$120-145k
The Recombinant Antibody Manager will be responsible for leading the Recombinant Antibody group by developing methods of achieving a high level of antibody expression and ensuring that those methods are implemented to product high quality antibodies. This position will functional as an integral part of the Recombinant Antibody Development and Production Teams.
PhD in Biochemistry, molecular biology, cell biology, bioengineering or related Biological Science area
5 years of related industry experience, focusing on transient and/or cell line development for recombinant antibody expression and production
Previous project management and personnel management experience
Expertise with stable cell line development for recombinant antibody production
Extensive experience with recombinant antibody engineering and development
Expertise with high level expression of recombinant antibodies in different expression systems such as CHO, NS0, and HEK 293
Technical expertise in cell culture and stable cell line generation, process development, and optimization
Experience with the scale up recombinant antibody production to an industrial level
Extensive experience with media optimization and scaling-up of bioreactor processes
Strong Microsoft Word, EXCEL, PowerPoint, and FM database skills
Familiarity with ISO 9001/ ISO13485, GLP or GMP compliance
Lead the Recombinant Antibody Program, which will include designing and optimizing recombinant antibody expression in both transient and stable expression systems
Develop and maintain detailed and accurate electronic records related to cell line development to support recombinant antibody manufacturing and process improvement
Interface with manufacturing groups to provide on time and accurate material transfer support
Analyze results of data and prepare recommendations for improvement or trouble shooting

Receptionist – CH – Sorrento Valley

$12-15/hr
Hours are 8-4:30pm. Mon-Fri
Prefer a Sci background (degree or exp in a lab setting). NOTE: They do animal research so it has to be someone that is ok with this.
Job is answering phones, filing, client interaction, ordering supplies, etc. Will learn the business side of things over time.

Lab Technician II – C – Sorrento Valley

Up to $21/hr
PART TIME – looking for a candidate who is IN SCHOOL that can work 20-30 hours per week
Job Description
Buffer & media preparation, washing glassware, autoclaving, ordering lab supplies, preparing fermenter vessels for use, general lab cleaning.
Performs a wide variety of laboratory tasks.
May make detailed observations, analyze data and interpret results. Maintains laboratory equipment and inventory levels for laboratory supplies buffers/media.
Will be responsible for buffer & media preparation in the research and development area, including experiments as required and outlined.
May also develop and maintain record keeping for experiments performed.
Performs limited troubleshooting and calibration of instruments.
Will perform glassware washing.
MUST HAVES
Buffer/media preparation experience, glassware cleaning experience, science lab background and/or coursework, basic understanding Microsoft Office
Skills/Experience
High school diploma or associate degree with relevant work experience, prefer someone without a bachelor's degree.
Typically requires a minimum of 1-2 years of related experience.
Professional or academic lab experience
Previous buffer and/or media preparation is required, lab support experience including cleaning glassware, autoclaving, able to learn tasks quickly and multitask, efficient in pipetting & sterile technique, able to work well in a team, preferred but not required experience – SDS-PAGE analysis, ELISA assay, protein purification, fermentation, protein conjugation

Doc Control Analyst II – C – Sorrento Valley