Sr Associate II, Quality Control Biochemistry

<p>This onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed</p><p></p><p><b>About This Role</b></p><p>We are seeking a highly experienced and motivated Biochemistry Senior Associate II to join the Biochemistry team at our RTP biologics drug substance manufacturing facility. The role will support advancing biochemistry laboratory activities, including method execution, troubleshooting, instrument validation, data interpretation, and participation in project teams.</p><p>This role primarily works independently with minimal supervision as needed, consults with management on key decisions.</p><p></p><p><b>What You’ll Do</b></p><ul><li><p>Act as the primary team lead and represent the team in absence of Manager</p></li><li><p>Conduct laboratory investigations (i.e. invalids, OOS, and atypical) and deviations</p></li><li><p>Reviews tests, approves release data, and issues certificates</p></li><li><p>Authors and review protocols, change control requests, and SOPs</p></li><li><p>Serve as a technical resource for the workgroup or project team, supporting both routine and non‑routine activities (including regulatory intelligence assessments)</p></li><li><p>Analyze complex data sets, prepare comprehensive technical summaries, and communicate results effectively to cross-functional partners</p></li><li><p>Provide informal guidance and mentorship to new or less experienced colleagues</p></li><li><p>Uphold high standards of data integrity, precise documentation, and strict adherence to cGMP/cGDP or other relevant regulatory requirements</p></li><li><p>Lead continuous improvement initiatives aimed at optimizing laboratory practices, operational efficiency, and scientific rigor</p></li><li><p>Support laboratory readiness by overseeing equipment qualification, calibration, and resolution of technical deviations</p></li><li><p>Function as the Subject Matter Expert (SME) for Biochemistry during regulatory inspections and audits</p></li><li><p>Perform biochemical assays and analytical methods with demonstrated expertise in one or more specialized areas, such as chromatography, electrophoresis, enzymatic assays, structural characterization, or protein purity/identity techniques</p></li><li><p>Perform technical training</p></li><li><p>Other duties as assigned</p></li></ul><p></p><p><b>Who You Are</b></p><ul><li><p>Strategic thinker skilled in analytical methods such as physical characterization, functionality assays, electrophoresis, protein characterization, and chromatography</p></li><li><p>Effective project manager with decisive leadership, thriving in fast-paced settings</p></li><li><p>Committed to continuous improvement, innovation, and proactive problem-solving</p></li><li><p>Actively contributes to technical discussions, communicates complex information clearly across teams, and supports new team members with guidance</p></li></ul><p></p><p><b>Required Skills</b></p><ul><li><p>Bachelor’s in Biochemistry, Chemistry, or related field (Master’s preferred)</p></li><li><p>Minimum 5&#43; years of QC Biochemistry experience in GMP biologics/pharma manufacturing</p></li><li><p>Deep knowledge of biochemistry or expertise in analytical disciplines, including chromatography, electrophoresis, enzymatic assays, structural characterization, or protein purity/identity techniques</p></li><li><p>Experience with complex OOS investigations and data interpretation (trends, anomalies, root causes)</p></li><li><p>Familiarity with regulatory inspections and audits</p></li><li><p>Working knowledge of regulatory requirements related to lab operations and method qualification/design (i.e. CFR, ICH, USP, etc)</p></li><li><p>Skilled with business technology tools and data systems (e.g., LIMS, Smart QC, Empower, Excel, PowerPoint)</p></li><li><p>Can explain complex issues simply and contribute to small cross-functional teams</p></li><li><p>Adapts effectively to ambiguity, developing solutions without established procedures</p></li><li><p>Strong written and verbal communication skills, along with proficiency in Microsoft Word and Excel.</p></li><li><p>Excellent organizational skills with the ability to prioritize, follow through on tasks, and meet deadlines.</p></li><li><p>Prior training experience, including classroom training</p></li></ul><p></p><p><b>Preferred Skills</b></p><ul><li><p>Project management experience</p></li><li><p>Leadership or supervisory experience</p></li><li><p>AI tool proficiency</p></li><li><p>Experience in method and instrument qualification</p></li><li><p>Knowledge of DI regulations</p></li><li><p>LEAN lab and Six Sigma training and/or certification</p></li></ul><p style="text-align:inherit"><br /> </p>Job Level: Professional<p style="text-align:left"><br /><b>Additional Information</b></p><p style="text-align:inherit"></p>The base compensation range for this role is: $93,000.00-$121,000.00<div><p style="text-align:left"><br /><span>Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills &amp; experience, job location, and internal equity.</span></p><p style="text-align:inherit"></p><p style="text-align:left"><span>Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. </span></p><p style="text-align:inherit"></p><p style="text-align:left"><span>In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families <i>physical, financial, emotional,</i> and <i>social well-being</i>; including, but not limited to:</span></p><ul><li><span>Medical, Dental, Vision, &amp; Life insurances</span></li><li><span>Fitness &amp; Wellness programs including a fitness reimbursement </span></li><li><span>Short- and Long-Term Disability insurance</span></li><li><span>A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)</span></li><li><span>Up to 12 company paid holidays &#43; 3 paid days off for Personal Significance </span></li><li><span>80 hours of sick time per calendar year</span></li><li><span>Paid Maternity and Parental Leave benefit </span></li><li><span>401(k) program participation with company matched contributions</span></li><li><span>Employee stock purchase plan </span></li><li><span>Tuition reimbursement of up to $10,000 per calendar year </span></li><li><span><span>Employee Resource Groups participation</span></span></li></ul><p style="text-align:inherit"></p></div><div><p style="text-align:left"><b>Why Biogen?</b></p><p style="text-align:left">We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.</p><p style="text-align:inherit"></p><p style="text-align:left">At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.<span> </span><a href="https://nam12.safelinks.protection.outlook.com/?url&#61;https%3A%2F%2Fwww.biogen.com%2Fresponsibility%2Fdiversity-inclusion.html&amp;data&#61;05%7C01%7Cdennis.mercier%40biogen.com%7C67adaf5a6edd4324716208db0dcd2182%7C7b7466bbfe1d47a0b9438ded565c8e54%7C0%7C0%7C638118946897044815%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata&#61;p2vFGx6ZWK7lyBEL4wuNIQJcKSVRZD90VuJxcOkjX04%3D&amp;reserved&#61;0" target="_blank">Read on</a><span> </span>to learn more about our DE&amp;I efforts.</p><p style="text-align:inherit"></p><p style="text-align:left">All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.</p></div>