Contract Process Development Associate II

<div class="content-intro"><p>At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.</p></div><p>This role is responsible for providing overall support in early stages of process development and acting as an interface with the Research and CMC organizations. This person will be responsible for executing and developing stage appropriate downstream processes for novel protein therapeutics. Developing downstream purification processes for expression scales that range from shake flasks to pilot scale bioreactors. Theis person will also be involved in providing and analyzing data and relevant information for reports supporting tech transfer activities for external manufacturing.</p> <p><strong>Responsibilities: </strong></p> <ul> <li>Hands-on execution, and optimization of protein purification processes including primary recovery unit operations (centrifugation, homogenization, flocculation, tangential-flow filtration (TFF), and depth filtration), chromatography (ion-exchange, affinity, hydrophobic interaction), and pre-formulation (TFF, dialysis)</li> <li>Generate and analyze process and analytical data supporting key documents such as development reports, regulatory submissions, and technology transfer packages</li> <li>Execute routine scale down protein purification with affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA systems (Unicorn software)</li> <li>Perform analyses including but not limited to UV-Vis Spectroscopy, SDS-PAGE, SE-HPLC, LAL, host cell-DNA, host cell protein, as necessary</li> <li>Buffer preparation and aseptic technique</li> <li>Drug substance and protein intermediate inventory management</li> <li>Work within the DSP group to explore novel purification processes as well as using standard methods to purify proteins</li> <li>Perform small-scale studies and pilot scale purification studies</li> <li>Apply DOE methods to purification activities</li> <li>Executing protocols, interpretation of data, and report generation</li> <li>Work with Co-Ops and helping them in their planning and activities as needed</li> <li>Maintain laboratory notebooks and digital records</li> <li>Present data at process development and CMC department meetings</li> <li>Operate and troubleshoot process equipment</li> <li>Chromatography, TFF including, UD/DF, micro filtration, nano filtration, and filtration</li> <li>Process scaling and/or technology transfer</li> </ul> <p><strong>Qualifications</strong></p> <ul> <li>B.S. (Graduate degree preferred MS and PhD) in Chemical Engineering, Biochemical Engineering, or an equivalent engineering/science degree with 1-3+ years of experience working in the biopharma industry.</li> <li>Experience in protein purification, scale up/down, process and analytical characterization</li> <li>Hands-on experience with purification unit operations including filtration, chromatography, TFF, UF/DF, AKTA, UNICORN and HPLC systems is a plus</li> <li>Comprehension of downstream processes at the small to an intermediate scale of cGMP biologics production</li> <li>Familiarity with automated chromatography platforms (e.g., Cytiva AKTA)</li> <li>Ability to work independently and as part of a cross-functional team</li> <li>Good oral and written communication skills</li> <li>Ability to adapt to frequent change and thrive in a dynamic early-stage environment</li> <li>Strong communication and organization skills, knowledge of MS Office, data plotting and graphing software. Must be able to communicate results effectively.</li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.<strong><em>&nbsp;</em></strong></p></div><div class="title">Potential base pay range</div><div class="pay-range"><span>$53</span><span class="divider">&mdash;</span><span>$62 USD</span></div></div></div><div class="content-conclusion"><p><span style="font-size: 12pt; font-family: 'trebuchet ms', geneva, sans-serif;"><strong><img style="max-width: 100%;" alt=""> <a href="https://diversityjobs.com/employer/top-diversity-employers?utm_campaign=TopEmployer&amp;utm_medium=badge"> <img style="max-width: 100%;" src="https://diversityjobs.com/imglib/employer-images/2023/employer-member.png" alt="DiversityJobs.com Employer Member" width="174"></a> </strong></span></p> <p><span style="font-size: 12pt; font-family: 'trebuchet ms', geneva, sans-serif;"><strong>Our Diversity, Equity &amp; Inclusion Mission Statement:</strong><strong> &nbsp;</strong>Keros is an inclusive company.&nbsp; We believe that diversity drives innovation.&nbsp; We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees.&nbsp; As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.</span></p> <p><span style="font-size: 10pt; font-family: 'trebuchet ms', geneva, sans-serif;"><em>Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.</em></span></p> <p><span style="font-size: 10pt; font-family: 'trebuchet ms', geneva, sans-serif;"><em><strong>Recruitment &amp; Staffing Agencies:<br></strong>Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly.&nbsp; Any unsolicited submission by an agency to Keros is prohibited.&nbsp; Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.</em></span></p></div>