Open Positions

 

Facilities and equipment maintenance technician

We’re hiring for a technical position that provides a sporting role, primarily for our QA and Manufacturing departments. In addition, the role may require partnering with other teams and groups as needed. This position reports to the Director of Quality, Engineering & Business. We operate our facility under the principles and guidelines of cGMP, and expect the same standards to be followed in all areas of work. The primary job responsibilities are:

• Oversight and maintenance of the Inventprise facility with the goal of ensuring smooth operation of the facility, process equipment, and any associated services.
• Develop and/or implement preventative maintenance and calibration programs.
• Co-ordinate with vendors to ensure that equipment repairs, calibration, maintenance, etc is carried out in a timely manner.
• Troubleshoot and identify equipment malfunctions.
• Supervise and perform various activities related to the general upkeep and cleanliness of the facility.
• Manage/co-ordinate waste-disposal activities with service vendors.
• Maintain the PM and Calibration schedule through our Quality Management System. (Paradigm)
• Evaluate/maintain equipment to ensure or improve safety.
• Ability to read mechanical drawings, construction schematics, equipment manuals, etc.
• Conduct routine facility checks to ensure the smooth operation of the facility.
• Follow all Standard Operating Procedures related to facilities and equipment.
• Document and maintain records related to process equipment use. Perform audits, record observations, and help drive the audit closures.
• Support QA activities – Participate in root cause investigations, corrective action implementations, and monitoring of correct action effectiveness. Initiate, assess, approve, track and trend deviations, and CAPA as required.

Qualifications:

• Associate’s Degree in Engineering or equivalent.
• High School diploma/GED with appropriate experience.
• Education and/or previous experience related to mechanical/electrical/HVAC equipment, including set-up and alignment
• Aptitude to effectively problem-solve and collaborate with others
• Ability to work well with minimal supervision

Required Experience:

• Basic computer skills, Microsoft Word, Excel, etc.
• 2 – 3 years experience in the Pharmaceutical / Biotechnology industry.

 

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Quality Control Analyst

We are looking for a motivated and skillful individual with a BS with 3-5 years of laboratory experience to join our quality control group as a Quality Control Analyst. This is an exciting opportunity to contribute to the success of both external as well as internal projects in our pipeline. Qualifications: The ideal individual will contribute to our team by having the following skills:

• Good aseptic technique and proficiency handling microbial cultures.
• Experienced or knowledgeable in working in a regulated cGMP environment.
• Hands on experience with chromogenic, chemical and/or biological assays.
• Knowledge of HPLC principles and techniques.
• Assay validation or qualification experience is desired.
• Excellent verbal and written communication skills.
• Proficiency in computer systems and Microsoft Office suite.
• Ability to strive in a fast-paced, creative, and goal-oriented environment.

Responsibilities:

• Plan, organize, and execute protocols, according to high scientific standards, under minimal supervision following GLP and GMP guidelines.
• Work independently as well as part of a team to perform a variety of assays according to current written protocols.
• Maintain accurate and detailed laboratory notebook and documentation according to regulatory guidelines.
• Effectively understand the meaning of assay results and be able to relay them to other team members.
• Identify any deviations in assay results and troubleshoot for potential causes when applicable.
• Periodically present results, and summarize progress to team members.
• Intellectually contribute to group goals by staying current with scientific literature and state-of-the-art methodology.
• Effectively prioritize tasks to meet goals and drive projects to completion according to timelines.

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Associate Scientist/ Scientist/ Sr. Scientist.

We are looking for a motivated and skillful individual with a MS degree in Biotechnology, Microbiology, Biochemistry, Virology or Cell Biology with 3 years (or BS with +5 years) hands-on experience with mammalian cell culture and a wide range of cellular assay techniques to join our viral vaccine development group as an Associate Scientist/ Scientist/ Sr. Scientist. This is an exciting opportunity to contribute to the development of both external as well as internal projects in our pipeline.

Qualifications:

• Vaccine manufacturing, with emphasis in virology.
• Highly skilled in setting and validating assays as per ICH Q2 (R1)
• Experienced with designing and troubleshooting qRT-PCR assays.
• Knowledgeable or experienced with viral growth and production in either cell monolayers, spinner flasks and/or bioreactors.
• Aseptic handling and maintenance of mammalian cell cultures in BSL-2 environment.
• Tissue culture media preparation, cryo-preservation, revival, and banking of cell lines.
• Experienced in developing and performing cell-based assays for viral titrations (PFU; FFU; CCID50; IU) using plaque assay, immunofluorescence focus assays and qRT-PCR.
• Skill sets to perform adventitious agents testing, haemadsorption testing and ELISA.
• Execute experiments for reference standards establishment and qualifying critical reagents for viral vaccines testing.
• Knowledgeable or experienced in working under regulated cGMP environment following FDA/ EMA/WHO guidelines.
• Experienced with molecular and diagnostic techniques such as Western blots; ELISA; SDS-PAGE electrophoresis; DNA and RNA extraction; PCR; and qRT-PCR.
• Preparation of Batch Records, SOP, and maintenance of proper laboratory notebooks.
• Excellent verbal and written communication skills.
• Proficiency in computer systems and Microsoft Office suite.
• Ability to strive in a fast-paced, multitasking, creative, and goal-oriented environment.
• Currently authorized to work in the US.

Responsibilities:

• Plan, organize, and execute experiments, according to high scientific standards, under minimal supervision following GLP and GMP guidelines.
• Work independently or in a team to perform, troubleshoot, evaluate, and propose experiments.
• Maintain accurate and detailed laboratory notebook and documentation according to regulatory guidelines.
• Periodically present results, and summarize progress to team members.
• Intellectually contribute to main goals by staying current with scientific literature and state-of-the-art methodology.
• Effectively prioritize tasks to meet goals and drive project to completion according to timelines.

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If you feel that your skill set matches our requirements, and are excited to join us in our goal of improving global health, email us your resume for evaluation at: jobs@inventprise.com