CAREER PORTAL

Analytical Method Development Technical Writer

Yoh Life Sciences is hiring for a ONSITE  contract Analytical Method Development Technical Writer  for our CDMO customer in San Diego, CA.     The individual will be responsible for authoring technical documents within the Quality Control (QC) and Analytical Method Development (AMD) groups in support of GMP large-molecule manufacturing activities.  Focus areas include author, edit, and review technical documents covering analytical development, qualification/validation and QC testing activities.  

Pay Range: $40 - 50/hr DOE
Location:   onsite M-F 9-5pm San Diego
Duration: ongoing contract 

Duties Include:

• Collaborate with subject matter experts in AMD, QC and QA to draft Analytical Test Methods (ATMs), qualification/validation protocols, qualification reports, investigations, and SOPs.
• Preparing documents for internal and external review, responding to internal and external reviewer comments, and revising accordingly.
• Utilize templates to rapidly draft and format technical documents.
• Translate experimental data and internal presentations into technical documents.
• Support and prioritize multiple projects concurrently while influencing cross-functional teams to ensure documentation is completed within specified timelines.
• Performs other related duties as assigned.

Qualifications/Skills Required:

• Minimum of B.S. degree in a scientific discipline with 5+ years of relevant experience in a pharmaceutical, biotechnology, or CRO in a GMP environment.
• Experience with preparing analytical test reports, qualification/validation protocols, qualification/validation reports, SOPs or other technical documents.
• Knowledge of the theoretical and practical aspects of some of the analytical methods utilized to characterize large molecule therapeutics such as: U/HPLC, CE, cIEF, ELISA, SDS PAGE.
• Strong planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Strong written and oral communication skills, proficient with Microsoft Office software, particularly Microsoft Word and Sharepoint.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Experience working in a deadline driven environment.
• Experience with the transfer and/or qualification/validation of analytical methods is a plus.
• Experienced with USP, EP and ICH guidelines.

 

Estimated Min Rate: $31.50
Estimated Max Rate: $45.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice:  https://www.yoh.com/privacy-notice