Senior Scientist - Analytical Sciences

Minaris•Philadelphia, PA

About The Position

Designs, plans, leads, authors, executes, and interprets research and development studies, assay qualifications and test article validations. Acts as a Technical Reviewer and assay trainer, including partnering with Testing Operations during assay transfers. Leads and drives technical discussions, both internally and externally with clients. Interfaces with Business Development team regularly and authors custom quotes, as needed. Essential Functions and Responsibilities Designs, plans, leads, executes, and interprets R&D and GMP studies. Conducts and directs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs. Conducts critical review of results and interprets the data. Draws conclusions and plans next steps for assay development or troubleshooting. Reports observations of ongoing tests to appropriate internal staff and clients, as needed. Writes research and development reports and ensures data are reported clearly and accurately. Excels in method troubleshooting and clearly communicates scientific knowledge both internally and externally. Demonstrates solid proficiency in scientific theory and rigorous practical application in the completion of lab procedures. Designs and executes R&D studies under limited supervision. Drafts and executes qualification protocols, validation protocols, and other GMP methods under minimal supervision of supervisor or other technical lead. Author reports related to studies. Interfaces with business development team regularly, including authoring custom quotes / quote sections Thorough understanding of Good Manufacturing Practices Serves as technical reviewer and performs all required functions in LIMS. General lab housekeeping, ordering reagents and materials, initiate work orders, as needed. Responsible for ELPRO monitoring and response. Participates in assay transfers to Operations. Serves as trainer for inter- and intra-departmental staff. Initiate and track change controls Author and execute IQOQ, author equipment SOP, participate in CSV activities as needed. Investigates and responds to equipment out of tolerances (OOTs). Performs equipment preventative maintenance (PMs), as needed. Drafts test methods, standard operating procedures (SOPs), reagent protocols (RPs) and client protocols (CPs) under minimal supervision. Participates in client calls and face to face meetings as a subject matter expert. Ability to work in a team environment and independently, as required. Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures. Attends scientific conferences / meetings, when feasible Regular and reliable attendance on a full-time basis. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.

Requirements

Strong virology knowledge and experience is required for this position.
Proven troubleshooting skills
Ability to use judgement as dictated by the complexity of the situation
Effective multi-tasking skill and time management required
Ability to evaluate technical data and record data accurately and legibly
Ability to understand and follow verbal and demonstrated instructions
Ability to clearly express and exchange ideas by means of verbal and written communication
Ability to work effectively as part of a team and exhibit effective interpersonal skills
Ability to work under limited supervision and to handle problems of a very difficult nature
Need to be able to read, write and understand English
Proficient in oral and written communication skills
Proficient in Microsoft (Excel, Word, Powerpoint and Outlook)
Bachelor's degree in Biological Sciences or science related field with 8 years of relevant, hands-on lab experience orMaster's Degree in Biological Sciences with 6 years of relevant experience or PhD in Biological Sciences with 2 years or relevant experience
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.

Nice To Haves

Experience with next generation sequencing is highly desirable.
Experience with gene therapy vectors and/or gene and non-gene mediated cell therapies is a plus.
Experience in a cGMP environment is highly desirable

Responsibilities

Designs, plans, leads, executes, and interprets R&D and GMP studies.
Conducts and directs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs.
Conducts critical review of results and interprets the data.
Draws conclusions and plans next steps for assay development or troubleshooting.
Reports observations of ongoing tests to appropriate internal staff and clients, as needed.
Writes research and development reports and ensures data are reported clearly and accurately.
Excels in method troubleshooting and clearly communicates scientific knowledge both internally and externally.
Demonstrates solid proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
Designs and executes R&D studies under limited supervision.
Drafts and executes qualification protocols, validation protocols, and other GMP methods under minimal supervision of supervisor or other technical lead.
Author reports related to studies.
Interfaces with business development team regularly, including authoring custom quotes / quote sections
Thorough understanding of Good Manufacturing Practices
Serves as technical reviewer and performs all required functions in LIMS.
General lab housekeeping, ordering reagents and materials, initiate work orders, as needed.
Responsible for ELPRO monitoring and response.
Participates in assay transfers to Operations.
Serves as trainer for inter- and intra-departmental staff.
Initiate and track change controls
Author and execute IQOQ, author equipment SOP, participate in CSV activities as needed.
Investigates and responds to equipment out of tolerances (OOTs).
Performs equipment preventative maintenance (PMs), as needed.
Drafts test methods, standard operating procedures (SOPs), reagent protocols (RPs) and client protocols (CPs) under minimal supervision.
Participates in client calls and face to face meetings as a subject matter expert.
Ability to work in a team environment and independently, as required.
Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures.
Attends scientific conferences / meetings, when feasible
Regular and reliable attendance on a full-time basis.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.