Job Description
Position Overview - Basic Functions & Responsibility
A robust analytical testing network is essential to realize our company’s mission and strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial product. The Senior Specialist, BCR Sciences is an individual contributor role accountable for critical reagent evaluation and qualification activities to realize uninterrupted supply of well-performing, qualified reagents for our Company’s growing inline large molecule product portfolio.
Effective communication and teamwork with internal and external partners are essential to the success of this role. The role is expected to participate in effective cross-divisional collaborations at both local site and global levels both with internal and external collaborations. Given the scope, this role requires strong technical expertise in general analytical laboratory operations, equipment and techniques.
The ideal candidate for this position will have significant working knowledge of GMP data/documentation as applied in a QC laboratory or analytical support function. This role will require strong communication and collaboration skills in addition to technical competencies in analytical platforms and data analysis. Planning and organizational skills to ensure effective communication with stakeholders (within and beyond Large Molecule Critical Reagents organization) are . Additionally, the candidate will be responsible for technical problem solving and collaboration with planning and analytical sciences teams to ensure work priorities are aligned with short/long term-reagent supply. This role will also strive to optimize legacy vaccine qualification practices while being aligned with approved capital investments for enhanced operational and digital capabilities.
Primary Activities
As a BCR Sciences Senior Specialist for Large Molecule Biologic Critical Reagents, this role is accountable for the following:
Provide ownership and accountability for critical reagent deliverables (e.g. qualification, re-certification, troubleshooting) which will include cross-functional support from BCR scientists, Analytical Sciences, LMAS scientists, CMC Regulatory, as well as AR&D scientists.
Complete the above work activities by target dates as per Large Molecule (LM) Critical Reagents S&OP process and aligned cross-functional integrated work plans (issued/approved by the LM Critical Reagent Planning and Controls team and based on collaboratively established, realistic standard lead times for core work activities).
Rapidly escalate and resolve issues through tier process.
Encourage team culture of transparency, support, and accountability.
Ensure characterization/qualification testing plans and acceptance criteria are technically sound and aligned with acceptable business risk per the process/analytical combined product control strategy (as per cross-functional collaboration with LMAS Analytical Sciences teams). This includes challenging existing procedures to introduce new options.
Participate in hoshin and MPS processes to establish principles and prioritized actions to continuously improve critical reagent activities, including opportunities to improve the rigor of reagent characterization, consistency of reagent performance, reliability of BCR supply, and/or business process efficiency.
Support product decision-making forums (such as APLC Steering Committee, Analytical Working Groups, Technical Product Council) and ensure critical reagent team contributes to and is informed of product strategies.
Participate in LMAS project portfolio process and enforce good project management practices across team. Prioritize and complete sanctioned project work according to aligned project plans.
Partner with LM Critical Reagents areas in the pipeline to support new reagent introduction activities, including establishment and maintenance of new critical reagent processes to meet evolving expectations (for example, product-specific reagent monitoring commitments).
Education Minimum Requirement:
Bachelors level or higher degree in a science or applied field that establishes technical foundation for analytical work (such as but not limited to chemistry, biochemistry, biology, microbiology, engineering)
Required Experience and Skills:
Minimum 7 years combined experience in an analytical support function including development, commercialization, and/or Quality Control roles.
Direct or indirect leadership responsibilities demonstrating effective collaboration, listening skills, personnel coaching, and ability to influence decisions across organizational levels
Familiarity with GMP analytical laboratory operations, analytical test methods, and LIMS
Direct experience executing GMP change control and supporting GMP deviation management practices, including 8-step investigations
Able to work independently, with guidance in only the most complex situations.
Preferred Experience and Skills:
Prior experience supporting critical reagent lifecycle activities
Lean/six sigma or internal company MPS experience, such as process mapping and value stream mapping, tier, or other demonstrated ability to improve business processes and/or apply currently available digital tools.
Excellent presentation, oral and written communications skills: ability to simplify complex situations to clear, focused, fit-to-purpose communication with target audience.
Experience supporting strategy or technical content for regulatory submissions/communications
Demonstrated willingness to learn new areas across new and incoming platforms or techniques (for both in-line and pipeline products), seek-to-understand and continuously improve mindset, and ability to rapidly acquire working competency in adjacent or new areas to drive positive change.
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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
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NoTravel Requirements:
10%Flexible Work Arrangements:
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12/10/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.