Microbiologist (Mid) - 30535

Job Title: Microbiologist (Mid) Location: Berkeley, CA Zip Code: 94710 Keyword's: #Berkeleyjobs; #Microbiologistjobs. Start Date: Immediate we put down Local candidates only Job Description: POSITION SUMMARY- This position is to support related QC Assay testing/validation for Inspire-01 project.

POSITION DUTIES & RESPONSIBILITIES

1. Capable of conducting microbiological method validation including bioburden, sterility, LAL (endotoxin), and virology methods supporting biopharmaceutical, clinical and development products. Responsibility including protocol and report write up.
2. Conduct execution of microbiological methods per approved protocols and testing of routine and investigational samples.
3. Familiarities with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological related methods.
4. Investigates questionable test results, writes protocol deviation report (PDR), investigation/test plans when applicable. Collaborates effectively with Quality Assurance validation on the method validation approach.
5. Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division. Write protocols, revises SOP"s affected by these compendial changes and changes arising as a function of a CAPA, per approved Change Control.
6. Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
7. Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
8. Strong computer skills (Word, Excel, Access, PowerPoint, LIMS, SAP).
9. Prior experience in a QC microbiology testing laboratory.
10. Ability to work independently with minimum supervision.

REQUIREMENTS/PREFERENCES

Education Requirement(s): * Minimum Education bachelor"s degree in microbiology or related science degree or technical field. Minimum Experience 2+ years of experience in microbiological method validation in pharmaceutical or related industry or an equivalent combination of education and experience.

INTAKE QUESTIONS;

• Give me an overview of the role: What is a day like in this role? From a candidate"s perspective, what"s exciting about this role and team? What does this role accomplish for the business. It is an analyst position who will be testing commercial and clinical samples for release. It is exciting as the candidates will learn hands on microbiological assays and possibly work on validation of methods. It helps the business get safety data for in process and final container of our products.
• Who will this person work with on a daily basis? With at team of 5-7 analysts and specialists
• Why is this role open? Is this more maintenance or new development work? It is due to increase in workload
• Location of this role (Onsite, Hybrid, Remote)? Onsite
• If Onsite, what sites are you open to them sitting at? Client
• If Hybrid, how often will they be required to work onsite?
• Tell me about the team dynamic/culture - long standing team that has worked together for years or fairly new team? How does the team work together? The team is a long standing team who has worked in the department for 10-20 years. The team dynamic is excellent. The help each other and each person is very flexible and efficient
• List top 5 must haves to be successful in this role? Stress that we may not be able to find candidates with every single item on their list - ask what is truly mandatory. Flexible, efficient, team oriented, leadership skills, good communication skills, and work in a dynamic environment
• Even if the description has already been updated by the hiring manager, go over the technology requirements so we understand what is needed. Experience in GMP environment, aseptic technique,
• What are the items that would be nice to have, but not an absolute must? micro experience, lab experience
• Are there specific companies or industries (not vendors, but clients) that you"ve seen the best candidates come from in the past? Pharma companies
• What is the long term plan for the role? Conversion potential? At this point there is no long term plan
• What does the ideal candidate background look like (ex: pharmaceutical specific background specific industry experience etc.)? Pharma background
• What are you not interested in seeing and why? Someone who is not flexible or have the proper education
• What kind of soft skills are you looking for? Computer skills, excel, word, LIMS
• Are you open to candidates relocating (on their own) or do you prefer local candidates? Local
• What is the highest level of education is needed for this position? Bachler"s degree
• Any certifications required for this role? No
• Hours per week? Any chance of OT? Shift start time? 40 hours per week, possible OT if needed, start time 7am or 8am. Some of the positions will include working on the weekend (Tuesday-Saturday)or ( Wednesday- Sunday) (Wednesday-Sunday)
• Any driving required? If so, what are they driving? How often? No
• Any travel required? If so, where? How often? No
• What is the typical work environment? Will they be required any PPE? If so, is it provided ? Lab PPE
• Standard Dress Code? Casual
• How have you filled these Requisitions in the past? No, but similar positions
• Will you plan on interviewing these candidates? Interview process? Who from the team will be involved? Phone screen or face-to-face? Stress the importance of moving quickly - if we can avoid more than 1 interview per candidate, that will get someone in the door quicker. Online interview, need to hire quickly, lab associate director will interview
• Will there be training required for these roles? If so, when will the training be completed and how long will it be? Paid Training? On the job training once they start

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.