Job Title

Position Description

• To provide material R&D, characterization and analysis related to PVA sponges and to provide technical support through lab analysis internally and externally.
  

Position Responsibilities

• Responsible for hands-on work on PVA sponge formulation and lab-scale PVA sponge making.
• Support in-house and customer related analysis projects.
• Provide customer support, assistance for product development, and application support.
• Assist in providing technical marketing material.
• Assist the Sales Department with technical customer issues.
• Support Quality Department on analyzing and resolving customer complaint issues.
• Other job-related duties as assigned.

Position Requirements

• BS degree in Chemistry and/or Physical Science
• Minimum five (5) years experience in chemical laboratory environment, preferable minimum two (2) years minimum experience in polymer formulation and development.
• Strong PC skills.
• Excellent communication skills.
• Analytical skills.
• Technical report writing skills.
• Skilled in working in a team atmosphere.
• Customer relations experience.

Job Title

• Sr. Research Technician

Position Description

• Duties A position is available in the Cancer Signaling and Translational Oncology (in vivo Pharmacology) Department for a highly motivated individual to assist in evaluating new anti-cancer agents in xenograft models of human cancer.
• Principle responsibilities to support the in vivo group would entail performing sterile in vivo techniques, basic animal care and husbandry tasks, as well as administering test compounds, and collecting data.
• Additional responsibilities for this position would focus on general laboratory managerial duties such as stocking and ordering supplies, maintaining lab cleanliness, and appropriately disposing of biohazardous and chemical waste.
• The successful candidate will also be expected to perform administrative functions such as keeping accurate and up-to-date notes, attending select meetings, maintaining equipment and supply inventory, and having timely correspondences with the other lab members.
• Interaction with colleagues throughout the Cancer Signaling and Translational Oncology Department will be an important part of the job.
• Must be willing to work weekend days as required. Computer proficiency, especially Excel, is preferred.
• Must be capable of standing, lifting, kneeling, bending, etc., for extended periods of time. Must be willing to work with potentially hazardous materials and be able to lift a minimum of 50 pounds. 
  

Position Requirements

•  Excellent skills in communication, organization, flexibility and an eagerness to learn are required.
• Must work well in a team setting.
• Computer proficiency, especially Excel, is preferred.
• Experience with in vivo research a plus.
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

Position Description

• Oversee and coordinate day-to-day activities of fermentation team along with support technicians/lab aides to ensure smooth operation of cGMP fermentation activities.
• Report any issues that might impact fermentation to the Manager of fermentation, to which this position reports.
• Provide training to fermentation staff on fermentation processes and SOPs/BRs for GMP production. Coordinate all GMP activities including hands-on GMP fermentation.
• Write and review batch records as required.
• Complete QA batch record review.
• Coordinate/schedule fermentation department activities with cross functional departments (QA, FE, QE, PP, etc.) to maintain cGMP compliance. 
• Responsible for meeting production schedules within stated time frames and within both quality and cost objectives. 
• Recommend new processes, equipment, etc., to make operation more efficient. 
• Prepare lead technician employee evaluations.

Position Responsibilities

• Oversee and coordinate day-to-day activities of fermentation processes and fermentation staff in meeting the biopharmaceutical manufacturing in accordance with cGMP guidelines.
• Responsible for the training and maintenance of training binders for fermentation staff.
• Oversee and ensure the maintenance and performance of reactors and general upkeep of manufacturing fermentation GMP suites. 
• Ensure all raw material needs and supplies are available and maintained by fermentation staff. 
  Review and approve all LUMAC(s) related to Manufacturing fermentation. 
• Plan, coordinate and assist in the set-up of all the GMP fermentation activities and ensure suites and bio-reactors are functional for usage.
• Review the executed Production Batch Records and submit for Manager’s approval.
• Lead in the preparation and maintenance of cell bank inventory within the manufacturing Fermentation department.
• Coordinate all the routine maintenance and preventive maintenance activities with Facility Engineering and outside vendors. 
• Ensure the timely completion of work and in meeting our operational standards. 
• Collaborate with Pilot Plant fermentation for training and transfer processes when needed. 
• Work closely with Pilot Plant fermentation to troubleshoot manufacturing  processes.
• Perform trouble-shooting of instruments and processes.
• Perform technical training on the production floor and in a classroom setting.
• Batch Production Record Review.
• Execute in process/equipment validation protocols.
• Write technical development reports and, when necessary, give oral presentations of data at departmental or interdepartmental meetings.
  

Position Requirements

• Bachelor’s of Engineering in Biochemical Engineering/ Chemical Engineering, B.Sc./ M.Sc. in biology or related field with >8  years of relevant experience
• Minimum 5 years experience supervising a fermentation operation in a pharmaceutical or regulated environment.
• In depth experience in development and manufacturing of recombinant proteins by fermentation/ cell culture.
• Knowledge of hardware and software used in fermentation processes at intermediate to commercial scale (130L-2750L).
• Would possess comprehensive, hands-on experience with process equipments and ability to trouble shoot them.  
• Must possess a thorough knowledge of cGMPs and process validation requirements.
  

Job Title

• Reseearch Associate

Position Description

• Perform and support routine and non-routine analytcal and physical testing for starting materials, raw materials, intermediates in a fast-paced analytical and pharmaceutical chemistry lab utilzing HPLC, IC, GC, MS, Karl-Fischer, TGA, DSC, and dissolution apparatus.

Position Requirements

• Knowledge and hands-on laboratory experience in wet chemistry skills. Preference is given to candidates who are familiar with using various analytical instrumentations such as HPLC, GC, IC, MS, Karl-Fischer, DSC, and TGA.
• Prior experience working with Chemstation and Empower is desirable. Must be a computer literate and able to analyze, organize, and present data in Excel and PowerPoint.
• BS/MS in Chemistry or related field with 1+ years relevant experience in biotech or pharmaceutical industry.
  
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Medical Director, Clinical

Position Description

• Identify, assess and appropriately manage safety signals Phase 1- Phase 4. 

Position Responsibilities

• Review safety reports and safety sections for labels. Possess familiarity with biostatistics and computer data processing techniques. Must have strong interpersonal and leadership skills, self motivation, integrity, ethics and a solid commitment to drug safety.
• Review and evaluate serious event reports
• Communicate safety assessments 
• Medical review for safety sections of protocols, study reports, labels and investigator brochures. 
• Work with Quality Assurance, Document Management, Clinical teams, Legal,and Regulatory Affairs

Position Requirements

• Associate Director- 1 to 3 years of clinical experience within a private practice or academic medical setting. 
• Medical Director- 2 years of drug safety experience: 
• Senior Medical Director requires 5 years.  
• MD/DO board certified in internal medicine or family medicine is preferred. 
• Clinical pharmacology or clinical trial experience is also preferred.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Sr. Research Associate

Position Description

• The individual will develop and run cell based assays to support small molecule compound progression and characterization. Assays will be run using both primary human cells, whole blood and engineered cell lines.
  

Position Requirements

• Cell culture (primary human cells and cell lines).
• Purification of primary human immune cells by magnetic selection (Miltenyi beads).
• Western blotting
• Proliferation assays
• Flow cytometry (preferred but not essential)
• Transfection of cell lines and generation of stable cell lines/clones.
• Experience working with small molecules preferred but not essential
• Background in immunology
• MS (cellular immunology or related subject) plus >5 years relevant industry experience).
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• QC Associate

Position Description

• Perform chemistry and microbiology based assays such as pH, protein concentartion by UV-Vis spec scan, Total Organic Carbon (TOC), endotoxin determination by LAL (kinetic and gel clot methods), product and water bioburden, EM sampling, and readouts.

Position Requirements

• Prior microbiology or Environmental QC experience a plus. All testing performed in a cGMP environment.
• Ability to work well with others in a positive and collaborative manner Computer literacy and experience working in a cGMP environment.
• Strong work ethic and problem solving skills.
• Work schedule is Thursday-Sunday dayshift, 4 x 10 hour shift.
• BS/BA in Biochemistry, Chemistry or related field with minimum of 2 years experience.
  
   

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

• Research Associate

Position Responsibilities

• The Late Stage Pharmaceutical and Device Development group at the sponsor has an open position for a Research Assistant/ Research Associate.
• The individual will be responsible for conducting research and development activities for therapeutic protein formulations and delivery devices.
• This role will include optimizing protein formulations, in-process product stability studies, biophysical analysis, device characterization, and contributions to regulatory filings as the products near market launch. Applicants should be comfortable working both independently with minimal supervision, and as part of a team.
  

Position Requirements

• Strong analytical skills and experience characterizing proteins with multiple HPLC techniques (SEC, IEC, RPLC, etc.) and electrophoretic methods (iCIEF, SDS-CE) are preferred.
• Candidates should possess strong problem solving abilities, initiative, and organizational skills.
• Excellent oral and written communication, documentation, and interpersonal skills are required to facilitate multi-departmental interactions and collaboration with others.
• Candidates must have a bachelors or masters degree in protein biochemistry, chemistry, analytical chemistry, or bioprocess science with 2 -6 years of relevant laboratory experience.
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

• Clinical Safety Associate II

Position Description

• The Clinical Safety Associate II assists in the clinical processing of
  adverse event (AE) information received by sponsor.
• Responsibilities are performed under the direction of the Manager, Case Management.

Position Requirements

• Demonstrates advanced knowledge of safety concepts, focused on standards set
  out in ICH and FDA guidelines for drug safety reporting requirements and applies
  them in daily activities.
• Performs data entry and coding for all molecules.
• Performs a review of ancillary documentation accompanying ICSR reports and identifies pertinent clinical information for incorporation into the case narrative.
• RN, BSN, PA, NP, MSN, MD, or PharmD required
• Minimum 2 years of clinical experience in a health care related field
• Minimum 2 years of previous experience in Drug Safety required
• Computer proficiency and data entry experience preferred
• Excellent communication skills, both written and verbal
• Previous experience in Drug Safety (preferred)
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

Position Description

• The Compounder position is responsible for maintaining chemical inventories and doing basic QC testing.
  

Position Responsibilities

• Hot and cold blends.
• Maintain chemical inventories.
• Create batches - Blend & fill.
• Basic QC testing - ph, color matching, specific gravity, etc.
• Complete batch reports.
• Report problems to management.

Position Requirements

• Must be bilingual Spanish/English
• Must have blending/compounding experience.