Careers

Manager or Director, Business Development (Job Code. BD)

This is a work from home opportunity with some overnight travel required. You will be responsible to identify and secure new business as well as assist in maintaining an existing client base. Responsibilities include but not limited to:

• Proactively analyze market, implement sales tactics and achieve pipeline/sales target
• Identify and realize business opportunities in responsible territory/accounts
• Maintain and extend relationship with existing clients by guarantee clients’ satisfaction and address their needs timely
• Monitor market trends, competitive landscape and clients’ feedback; periodically report the information to senior management and related teams
• Generate publicity and influence of the company through networking, professional conferences and trade shows

Skills Required and/or Desired Exceptional communication (both written and verbal) are required and analytical skills are desired for this position.

• Pharmaceutical industries experience especially business development for contract laboratory required: 2 or 5 years of contract lab business development experience highly desired for manager or director position respectively
• Proven track record working with pharmaceutical companies both innovator and generic
• An ability to prospect for new relationships and secure new business
• An ability to work in a collaborative manner with laboratory operations/business units

Director, Formulation Development (Job Code: FD)

• Lead drug product formulation development for generics as well as innovative
• Lead all aspects of formulation development team at Primera including staff hiring and development, daily operation and compliance, budget and expense tracking, regulatory strategy, submission management and client interaction as well as team development
• Provide scientific and related regulatory expertise regarding formulation development ranging from generics reformulation, preclinical to clinical research phase as well as other late-phase formulation development NDA/ANDA/505b(2) to seek regulatory approval
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Interact closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements
• Write and review relevant reports for ANDA/IND/NDA applications
• Support business expansion with existing customers and broaden the customer basis by participating strategy development and business development activities (with respective business units)

Requirements:

• PhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8 years’ experience in pharmaceutical industries
• 3+ year experience in leading generics reformulation especially modified/extended release dosage forms with demonstrated successful ANDA or 505b(2) filing
• Innovative small molecule formulation development with demonstrated successful IND or NDA application filing highly desirable
• Excellent communication skills (oral, written, presentation), strong project management, team management and demonstrated problem solving skills
• Good knowledge of cGMPs, ICH guidelines, CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with government regulations, EMA/FDA CMC guidance documents will be an advantage
• Ability to work in a fast-paced, dynamic, environment

Senior Scientist, BioAnalytical Development (Job Code: BIO)

Duties and Responsibilities

• Conduct routine and non-routine analyses of test articles using biochemical methods including HPLC, LC-MS/MS, GC and USP dissolutions.  
• Perform routine and non-routine analytical testing using Ligand Binding assay.
• Perform bioanalytical method development and validation for PK and ADA.
• Operate plate reader for method development, method validation and sample analysis.
• Responsible for sample coordination, lab equipment maintenance, document management, inventory control and sample requests/documents reconciliation.
• Use scientific expertise to assist in troubleshooting, laboratory investigations and problem resolution.
• Compile data and prepare graphs for documenting test procedures and reports.
• Conduct document reviews, author Standard Operating Procedures (SOPs), and assay review.
• Conduct special projects including method validation, troubleshooting, optimization and investigations.
• Apply cGMP/GLP practices during execution of all work tasks.
• Update supervisor and clients the working progress at scheduled intervals.

Qualifications:

• Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Engineering or related field.
• 1 year of experience in cGMP/GLP and FDA guidelines and analytical methods including HPLC, GC, LC-MS, USP dissolution.
• Demonstrated ability to apply and implement GMP regulations into day to day tasks.

Scientist /Associate Scientist – Biologic Analytical Development (Job Code: BIO)

Job Description The Associate Scientist/Scientist – Biologic Analytical Development is responsible for the development and qualification of assays for biologic products. Duties and Responsibilities

• Participate assay development and optimization for ELISA, flow cytometry, bioassay, PCR and CE for biologic materials.
• Prepare methods for the transition to a GMP QC environment
• Author method procedures and SOPs
• Maintain sample and data integrity at all times
• Use sophisticated laboratory instrumentation and computer systems to collect and record data.
• Perform equipment maintenance and calibrations as required.
• Maintain lab readiness for audits by both internal and external authorities.
• Execute qualification/validation of analytical methods per ICH & USP guidelines

Qualifications:

• BS or MS in general science field, including but not limited to food science, Chemical Engineering, Biology and Healthcare. 
• 4-6 years of experience in a biologics laboratory with a BS or Master’s Degree and 2-4 years of related experience or Ph.D. and 2 years of related experience
• Knowledge of most laboratory equipment including but not limited to plate readers, cytometer, PCR & CE
• Experience in developing assays for a biological product
• Written communication skills require full competence in following detailed written instructions, creating/revising SOPs, protocols and reports
• Knowledge of chemical and biological safety procedures/precautions
• Proficient in Microsoft Office – Outlook, Word, Excel, Powerpoint

Scientist/Associate Scientist – Analytical Development (Job Code: ANA)

Duties and Responsibilities

• Conduct routine and non-routine analyses of test articles as assigned by supervisor by appropriate analytical chemistry methods such as: HPLC, LC-MS/MS, GC, USP dissolutions etc.
• Demonstrate initiative to perform routine laboratory responsibilities such as sample coordination, lab equipment maintenance, document management, inventory control, and reconciliation of sample requests/documents as needed.
• Monitor laboratory equipment for temperature and conformance to specifications.
• Apply acceptable cGMP/GLP practices during execution of all work tasks.
• Work independently with minimal or moderate supervisory guidance. Exhibit strong teamwork skills.
• Update supervisor of progress at scheduled intervals or frequent basis. Seek additional guidance as needed.
• Use scientific expertise to provide assistance for troubleshooting, laboratory investigations, and problem resolution. Suggest process improvements to management.
• Compile data and prepare graphs for documentation of test procedures and preparation of reports.
• Conduct document reviews, author standard operating procedures (SOPs), and assay review.
• Lead special projects such as method validation, troubleshooting, optimization, and investigations (Scientist)

Qualifications:

• BS or MS in general science field, including but not limited to food science, Chemical Engineering, Biology and Healthcare. 
• BS requires 1-5 years and a MS requires 0-3 years of previous related experience for Scientist (Fresh graduates with BS will be considered for Associate Scientist)
• Excellent working knowledge of cGMP/GLP regulations is required.
• Ability to work independently and achieve problem resolution with minimal or moderate supervision.
• Excellent teamwork and communication skills. Attentive to detail. Good computer skills.

Scientist – PK & ADME (Job Code: DMPK)

Summary of the Job Validation and routine execution of a range of in vitro ADME assays including permeability, metabolic stability, tissue/protein binding, solubility, drug-drug interaction, and in vivo PK studies, including study design, sample preparation, sample analysis using LC-MS/MS, and data report to support drug discovery and development for clients. Implementation of new technologies/sciences within the areas of expertise to improve the data quality of the studies in screen and selection of drug candidates. Duties and Responsibilities

• Comply with all the Standard Operating Procedures applicable to the job tasks.
• Conduct assays and sample preparations following established procedures to support drug discovery programs of the clients.
• Operate LC-MS for compound tuning, method development, and sample analysis.
• Assist development of new assays to help improve service capabilities.
• Assist troubleshooting of the issues/problems arisen from the assays and execute solutions for problem solving.
• Maintain detailed records and notebooks to assist method/report writing and data interpretation.
• Train other scientists in running established assays.

Qualifications:

• PhD in Biology, Chemistry or related discipline with greater than 2 years, Master’s Degree with greater than 5 years, or Bachelor’s Degree with greater than 8 years’ experience in a laboratory environment
• Expertise in advanced experimental methods including cell culturing skills as well as the concepts and techniques relevant to scientific discipline.
• Scientific/technical independency and creativity.
• Ability to expand knowledge in the relevant scientific discipline through related scientific literature.
• Ability to conduct researches collaboratively and propose methodologies for projects.
• Attention to detail and awareness of potential impact from any concerns.
• Good at written communication and oral presentation

Scientist – Bionalytical (Job Code: BA)

Duties and Responsibilities

• Perform routine and non-routine analytical testing using variety of analytical techniques such as: LC-MS/MS, HPLC, GC, etc.
• Perform bioanalytical method development and validation independently with minimum supervision.
• Operate LC-MS for compound tuning, method development, and sample analysis.
• Demonstrate initiative to perform routine laboratory responsibilities such as sample coordination, lab equipment maintenance, document management, inventory control, and reconciliation of sample requests/documents as needed.
• Following cGMP/GLP regulations when executing his/her daily work load.
• Update supervisor his/her work progress at scheduled intervals.
• Apply his/her scientific expertise for analytical methods/instruments troubleshooting, laboratory investigations, etc.

Qualifications:

• BS or MS (preferred) in a related science such as Chemistry or Pharmacology.
• BS requires 1-5 years and a MS requires 0-3 years of previous related experience
• Basic working knowledge of cGMP/GLP regulations is required.
• Ability to work independently and achieve problem resolution with minimal supervision. Attentive to detail.
• Excellent teamwork and communication skills.
• Good computer skills, profound knowledge with Microsoft word, Excel, and PowerPoint.