Downstream Technician

Oncobiologics Cranbury, NJ
About the OrganizationMission Statement:

Oncobiologics is a publicly traded biopharmaceutical company focused on the advancement of its pipeline of biosimilar products, two of which are currently in clinical development. Led by a team of biopharmaceutical experts, Oncobiologics operates from a state-of-the-art 40,000 sq. ft. fully-integrated R&D and manufacturing facility in Cranbury, NJ. The company employs its BioSymphony development model to ensure that biosimilar assets meet the stringent requirements of U.S. and European regulators, while also achieving accelerated development and technical excellence in creating affordable medicines for global patients who so urgently need them.

Oncobiologics provides a scientifically disciplined and speed-to-market approach to biosimilar development. By leveraging its scientific talent and technical infrastructure, the company has established a unique CMC engine designed to provide scientific rigor, speed and cost efficiencies. Through these capabilities, Oncobiologics is uniquely positioned to deliver a robust CMC package as required by the FDA, EMA and other regulatory bodies. The company is executing a commercial strategy to advance its biosimilar assets to global markets.

Oncobiologics actively fosters a collaborative, entrepreneurial culture. With years of experience in large organizations, the Oncobiologics team understands the critical importance of agile, rapid decision-making and strives to infuse all activities with urgency, creativity and disciplined thinking.

Key Facts:

Founded January, 2011

Employees: ~64

Focused on the development of 'large molecules' (i.e., biologics) Description

Opportunity and Summary of Position:

The Supervisor, Downstream Operations, will execute and supervise downstream manufacturing operations as Oncobiologics continues its rapid growth. The Supervisor, Downstream Operations, will be required to execute and supervise cGMP operations within the Biologics Manufacturing Center. This is an exempt position.

Reporting Relationships:

Supervisor, Downstream Operations, will report to the Group Leader, Downstream Operations.

Position Responsibilities:

* This position will work diligently to meet scheduled timelines, and will work as required to meet production schedule. Weekend, holiday and shift work will be required based on manufacturing schedule as determined by Area Management.

* Performance and oversight of Downstream cGMP Operations in accordance with Standard Operating Procedures (SOP's); Master Batch Records (MBR's); Equipment Qualification Protocols; and other applicable instructional documentation.

* Communicates status of operations, troubleshoots process issues, and remedies safety & maintenance issues with Area Management.

* Provides review of executed documentation for completeness and accuracy and works with Quality Assurance to reconcile comments.

* Participate in starting up facility and process equipment.

* Reviews, revises and authors SOPs, Deviations and Change Controls as directed by area management.

* Innovate technologies that embrace QRM, continuous improvement, reduce manufacturing costs and increase manufacturing efficiency

* Ensures that all production equipment is functioning properly and production processes meet documented quality standards.

* Follow all company best practices to minimize cost and meet budgetary requirements.

* Management team may assign other responsibilities as required.

* Mentor a staff of up to six (6) direct reports.

Position Requirements

Candidate Qualifications:

The company isCandidate Qualifications:

The company is seeking an individual with the following qualifications and who is willing to make a long-term commitment to the organization:

* Education/Certification

* B.S. Life Sciences or equivalent

* Qualifications and Skills

* 6 + years progressive industry experience within a downstream biologics drug substance manufacturing environment.

* Superior ability in cGMP bioprocess operations, particularly downstream processes, of mammalian expressed glycoproteins or mAbs

* Chromatography

* Tangential flow filtration

* Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration

* Due to international nature of the tasks, fluency in written and spoken English

* Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams

* A "hands-on" energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done

* Physical Requirements:

* Meets physical requirements of the job, as follows: must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks

* Must have the ability to stand for long periods of time.

* Works in production environment with exposure to latex and bleach. Potential exposure to equipment movement hazards, noise, dangerous materials, freezer burns, allergens and strong odors. Following proper safety procedures minimizes potential for exposure.

* Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE).job, as follows: must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks

* Must have the ability to stand for long periods of time.

* Works in production environment with exposure to latex and bleach. Potential exposure to equipment movement hazards, noise, dangerous materials, freezer burns, allergens and strong odors. Following proper safety procedures minimizes potential for exposure.

* Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE).

LocationOncobiologics EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.